{ "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. 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PRECISION XTRA METERS ARE GUARANTEED TO BE FREE FROM DEFECTS IN MATERIAL AND WORKMANSHIP FOR A PERIOD OF NO MORE THAN 4 YEARS FROM THE DATE OF PURCHASE. AS THE MANUFACTURING DATE OF THIS PRODUCT IS BEFORE 2010, IT HAS BEEN IN DISTRIBUTION BEYOND ITS USEFUL LIFE AT THE TIME OF THE COMPLAINT. SINCE THE PRODUCT EXCEEDED ITS USEFUL LIFE, IT IS DETERMINED TO HAVE MET SPECIFICATION WHEN THE PRODUCT WAS RELEASED AND THROUGH ITS LIFESPAN. NO FURTHER INVESTIGATION ACTIVITIES ARE BEING PERFORMED AT THIS TIME. NOTE: THE DEVICE MANUFACTURER DATE FOR THE REPORTED METER SERIAL NUMBER IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT." }, { "mdr_text_key": "189244952", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT." }, { "mdr_text_key": "189668974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVALUATIONS, AND LABEL COPY. THE INVESTIGATION DID NOT IDENTIFY ANY INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. IF THE PRODUCT IS RETURNED, AN INVESTIGATION WILL BE PERFORMED. NOTE: THE DEVICE MANUFACTURER DATE FOR THE REPORTED METER SERIAL NUMBER IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THIS SERVES AS A CORRECTION REPORT. THE SERIAL NUMBER PROVIDED BY THE CUSTOMER IN THE INITIAL REPORT WAS DEEMED INVALID UPON EXTENDED INVESTIGATION AND THEREFORE HAS BEEN UPDATED TO UNKNOWN. THEREFORE SERIAL NO, EVALUATION CODES AND ADDTL MFG NARRATIVE WERE INCORRECTLY DOCUMENTED IN INITIAL REPORT. THE CORRECTIONS HAVE BEEN MADE." }, { "mdr_text_key": "189668975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS 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": "04/29/2020" } ] }