{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 12150566 } }, "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": "1823260-2020-01110", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K043474", "date_of_event": "20200202", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "CA", "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": "465213", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "ACCU-CHEK ® PERFORMA TEST STRIPS", "generic_name": "BLOOD GLUCOSE MONITORING TEST STRIPS", "manufacturer_d_name": "ROCHE DIAGNOSTICS", "manufacturer_d_address_1": "9115 HAGUE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "INDIANAPOLIS", "manufacturer_d_state": "IN", "manufacturer_d_zip_code": "46250", "manufacturer_d_zip_code_ext": "0457", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "462500457", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "05942861164", "lot_number": "477424", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LFR", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Glucose Dehydrogenase, Glucose", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1345", "device_class": "2" } } ], "product_problems": [ "Incorrect Measurement", "Incorrect Measurement" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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 Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000033", "removal_correction_number": "NA", "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": "222555296", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CUSTOMER'S METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE TEST STRIPS ARE NOT EXPECTED TO BE RETURNED. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. THIS EVENT OCCURRED IN (B)(6)." }, { "mdr_text_key": "222555297", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE RESULTS FROM AN INFORM II METER WITH SERIAL NUMBER (B)(4) (METER A) WHEN COMPARED TO AN INFORM II METER WITH SERIAL NUMBER (B)(4) (METER B). QUALITY CONTROLS (QC) WERE RUN ON METER A THE DAY BEFORE THE EVENT ((B)(6) 2020) AT 10:46 AM. BOTH LEVELS OF CONTROL PASSED: LEVEL 1: 2.4 MMOL/L (RANGE: 2.1-2.7 MMOL/L), LEVEL 2: 16.7 MMOL/L (RANGE: 15.7-17.9 MMOL/L). THE RESULT FROM METER A WAS 14.1 MMOL/L AT 2:48 AM. THE RESULT FROM METER B WAS 3.3 MMOL/L AT 2:52 AM. THE SAME PERSON PERFORMED BOTH TESTS. THE RESULT FROM METER B WAS BELIEVED TO BE CORRECT. QC WAS THEN RUN ON METER A WITH FAILING RESULTS: LEVEL 1 RESULTS (RANGE: 2.1-2.7 MMOL/L): AT 2:56 AM THE RESULT WAS 2.8 MMOL/L (FAIL). AT 2:57 AM THE RESULT WAS 3.1 MMOL/L (FAIL). LEVEL 2 RESULT (RANGE: 15.7-17.9 MMOL/L): AT 2:57 AM THE RESULT WAS 16.1 MMOL/L (PASS). THE INITIAL REPORTER STATED THERE WAS A \"BLUE RESIDUE\" WAS IN THE STRIP PORT OF METER A. IT IS UNKNOWN IF THE METER WAS CONTAMINATED BEFORE OR AFTER THE EVENT." } ], "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": "" } ] }