BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4961517 · Received July 30, 2015

    Report

    Report Number
    1052693-2015-01310
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 30, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LO BLOOD GLUCOSE TEST RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 120 MG/DL. TESTING PERFORMED TWICE DAILY. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED NON-FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 225 MG/DL AND 267 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPEC. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/26/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1: 220 MG/DL, (B)(6) 2015, 03:51 PM; 2: 198 MG/DL, (B)(6) 2015, 03:50 PM; 3: 30 MG/DL, (B)(6) 2015, 03:49 PM; 4: 206 MG/DL, (B)(6) 2015, 03:48 PM; 5: LO, (B)(6) 2015, 03:47 PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495797 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RR4508

    Patients

    Seq Age Sex Outcome Treatment
    1