{ "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": 7604 } }, "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": "1319809-2020-00057", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200406", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "471794", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200428", "brand_name": "VITROS CHEMISTRY PRODUCTS GLU SLIDES", "generic_name": "IN VITRO DIAGNOSTICS", "manufacturer_d_name": "ORTHO-CLINICAL DIAGNOSTICS", "manufacturer_d_address_1": "100 INDIGO CREEK DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "ROCHESTER", "manufacturer_d_state": "NY", "manufacturer_d_zip_code": "14626", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "14626", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210501", "model_number": "", "catalog_number": "1707801", "lot_number": "0002-0973-4292", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "CGA", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "1319809" ], "fei_number": [ "1000305840" ], "device_name": "Glucose Oxidase, Glucose", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1345", "device_class": "2" } } ], "product_problems": [ "Low Test Results" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20200428", "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": "20200428", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10007142", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "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": "218021755", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS GLUCOSE (GLU) RESULT WAS OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0002-0973-4292 IN COMBINATION WITH A VITROS 350 CHEMISTRY SYSTEM. THE CAUSE OF THE EVENT IS ATTRIBUTED TO USER ERROR ASSOCIATED WITH THE MANUAL ENTRY AND USE OF CALIBRATION PARAMETERS FROM A PREVIOUS GLU SLIDE LOT. THE CUSTOMER HAD ERRONEOUSLY ENTERED THE CALIBRATION PARAMETERS FROM A PREVIOUS LOT OF VITROS GLU REAGENT INTO THE VITROS 350 CHEMISTRY SYSTEM FOR VITROS GLU LOT 0002-0973-4292 INSTEAD OF DOING A WET CALIBRATION AS PER ROUTINE PROCESS. THE VITROS GLU QUALITY CONTROL RESULTS WERE ACCEPTABLE AFTER A NEW CALIBRATION EVENT WAS PERFORMED USING VITROS GLU REAGENT LOT 0002-0973-4292 INDICATING VITROS GLU LOT 0002-0973-4292 IN COMBINATION WITH THE VITROS 350 SYSTEM WAS RETURNED TO THE EXPECTED PERFORMANCE." }, { "mdr_text_key": "218021756", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS GLUCOSE (GLU) RESULT OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES IN COMBINATION WITH A VITROS 350 CHEMISTRY SYSTEM. VITROS PV II LOT J6978 VITROS GLU RESULT OF <20 MG/DL VERSUS AN EXPECTED RESULT OF 288.9 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS GLU RESULT WAS FROM A QUALITY CONTROL FLUID. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4)." } ], "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": "" } ] }