{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 3833 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "8020790-2020-00041", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K921302", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "U" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RS", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "465872", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "VIDAS HCG", "generic_name": "VIDAS® HCG", "manufacturer_d_name": "BIOMERIEUX SA", "manufacturer_d_address_1": "CHEMIN DE L ORME", "manufacturer_d_address_2": "", "manufacturer_d_city": "MARCY L ETOILE, RHONE 69280,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200715", "model_number": "", "catalog_number": "30405", "lot_number": "1007502730", "other_id_number": "", "device_availability": "No", "device_report_product_code": "JHI", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "8020790" ], "fei_number": [ "1000611339" ], "device_name": "Visual, Pregnancy Hcg, Prescription Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1155", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/03/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200629", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002322", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317650387", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN RUSSIA REGARDING FALSE POSITIVE HCG RESULTS FOR THREE (3) SEPARATE PATIENTS (B, C AND D) IN ASSOCIATION WITH VIDAS® HCG 60 TESTS (REFERENCE (B)(4), LOT 1007502730). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: CUSTOMER'S MATERIAL. -NO SAMPLE AND NO KIT WERE RECEIVED FOR INVESTIGATION. COMPLAINT TRENDING ANALYSIS. NO RECURRENCE OF THE CUSTOMER'S ISSUE FOR VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0 WAS FOUND. STUDY OF BATCH HISTORY RECORD. -THERE IS NO CAPA, NOR NON-CONFORMITY RECORDED ON VIDAS HCG REF (B)(4) LINKED TO CUSTOMER'S ISSUE. -THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. CONTROL CHARTS ANALYSIS -THE COMPLAINT LABORATORY OBSERVED FOUR (4) INTERNAL SAMPLES ON 5 DIFFERENT BATCHES OF VIDAS HCG REF (B)(4) INCLUDING CUSTOMER'S LOT. HCG7 : TARGET 17.40 MUI/ML ; RANGES [12.42 - 22.38]. HCG9 : TARGET 28.80 MUI/ML ; RANGES [21.60 - 36.00]. HCG16 : TARGET 0.00 MUI /ML ; RANGES <= 2.00. HCG24 : TARGET 0.52 MUI/ML ; RANGES <= 2.24. -THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. -THE CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED. -THE COMPLAINT LABORATORY TESTED FOUR (4) INTERNAL SERA, SAME AS ABOVE IN CONTROL CHARTS ANALYSIS, WITH RETAIN KIT VIDAS HCG REF 30405 LOT 1007502730/ 200715-0. - ALL INTERNAL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS. THERE WAS NO DRIFT OF THE CUSTOMER'S LOT SINCE ITS RELEASE. -THE COMPLAINT LABORATORY TESTED CONTROL C1 WITHOUT SPR AND PERFORMED SPR AND STRIP WITHOUT SAMPLE.THESE TWO (2) ASSAYS GAVE NEGATIVE RESULTS <2 MUI/ML. CONCLUSION. COMPLAINT LABORATORY PERFORMED FOUR (4) INTERNAL SAMPLES, WITH THE RETAIN KIT VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0. THERE WAS NO ANOMALY. ALL INTERNAL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS. WITHOUT CUSTOMER'S RETURN SAMPLE AND KIT FURTHER INVESTIGATION CANNOT BE COMPLETED TO DETERMINE A ROOT CAUSE. THOUGH NOT CONFIRMED BY THE CUSTOMER IN THIS CASE, INTERNAL TESTING WITHOUT SPR AND/OR SAMPLE HAS DEMONSTRATED UNDERESTIMATED RESULTS. -ACCORDING THE ABOVE DATA , THE KIT VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0 WAS WITHIN THE EXPECTED PERFORMANCES. THERE WAS NO DRIFT OF THE BATCH SINCE ITS RELEASE." }, { "mdr_text_key": "207755676", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE HCG RESULTS FOR A PATIENT IN ASSOCIATION WITH VIDAS® HCG 60 TESTS (REFERENCE 30405, LOT 1007502730). A SUMMARY OF TEST RESULTS IS LISTED BELOW 1ST TEST: POSITION A2 RESULT: 757.60 MUI/ML. 2ND TEST: POSITION A1 RESULT: <2 MUI/ML WITH -6 RFV. 3RD TEST: POSITION A1 RESULT: 24.78 MUI/ML. POSITION B1 RESULT: 22.20 MUI/ML. THE CUSTOMER CONFIRMED THE INCORRECT TEST RESULTS WERE PROVIDED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION. NOTE: VIDAS REFERENCE 30405 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES HOWEVER, A SIMILAR INSTRUMENT IS MARKETED IN THE UNITED STATES UNDER REFERENCE NUMBER 30405-01." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/29/2020" } ] }