{ "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": 105 } }, "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": "1823260-2021-00915", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210325", "manufacturer_address_2": "", "pma_pmn_number": "K951595", "date_of_event": "20210304", "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", "USER FACI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210325", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "465472", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210325", "brand_name": "CHOL2 CHOLESTEROL GEN.2", "generic_name": "ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL", "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", "expiration_date_of_device": "20210731", "model_number": "NA", "catalog_number": "03039773190", "lot_number": "50861001", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "CHH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Enzymatic Esterase--Oxidase, Cholesterol", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1175", "device_class": "1" } } ], "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": "03/04/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20210325", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210616", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11567768", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20210304", "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": "324626315", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CUSTOMER BELIEVED THE ISSUE WAS SAMPLE SPECIFIC. ULTRACENTRIFUGATION OF LIPEMIC SAMPLES HAS NOT BEEN VALIDATED. IF THE CUSTOMER WISHES TO ULTRACENTRIFUGE LIPEMIC SAMPLES, THEY WILL NEED TO PERFORM THEIR OWN VALIDATION OF THE METHOD. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO THE PREANALYTIC HANDLING OF THE SAMPLE." }, { "mdr_text_key": "266241567", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE IDENTIFIER (UDI) # (B)(4). THE INVESTIGATION IS ONGOING." }, { "mdr_text_key": "266241568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE CHOL2 CHOLESTEROL GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 483 MG/DL AND THE ULTRAFUGED REPEAT RESULT WAS 215 MG/DL. THE CUSTOMER STATED THEY DID NOT KNOW WHICH RESULT WAS CORRECT, BOTH RESULTS WERE VERBALLY PROVIDED TO THE PHYSICIAN AND THE PHYSICIAN DECIDED TO ORDER A REDRAW. NO INFORMATION REGARDING THE REDRAW RESULTS WERE PROVIDED." } ], "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": "06/16/2021" } ] }