BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4999140 · Received August 6, 2015

    Report

    Report Number
    1052693-2015-01325
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 7, 2015
    Report Date
    December 8, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED, BUT EVALUATION PENDING TO COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER'S TEST STRIP HAD POOR STORAGEINVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. ADDITIONAL PRODUCT CODES ADDED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE TEST RESULTS. EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 190 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION AS A RESULT OF METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2017 AND OPEN VIAL DATE IS WEEK OF (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 104MG/DL, (B)(6) 2015, 03:07PM; 212MG/DL, (B)(6) 2015, 03:06PM; 202MG/DL, (B)(6) 2015, 03:04PM; 261MG/DL, (B)(6) 2015, 03:03PM; 200MG/DL, (B)(6) 2015, 03:02PM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE TEST RESULTS. EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 190 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION AS A RESULT OF METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2017 AND OPEN VIAL DATE IS WEEK OF (B)(6) 2015. (B)(6). ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521299 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4626

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR