BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 5477580 · Received March 3, 2016

    Report

    Report Number
    1052693-2016-00428
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 8, 2016
    Report Date
    March 3, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES THAT SHE FEELS PHYSICALLY FINE, DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 180MG/DL FASTING. VERIFIED TEST STRIPS EXPIRATION DATE IS 04/24/2017. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY AND OPENED VIAL DATE (B)(6) 2016. REVIEWED METER MEMORY: 1:271MG/DL (B)(6) 2016 08:25:00 AM FASTING:YES, 2:426MG/DL (B)(6) 2016 06:46:00 AM FASTING:YES, 3:502MG/DL (B)(6) 2016 06:27:00 AM FASTING:YES, 4:278MG/DL (B)(6) 2016 06:26:00 AM FASTING:YES, 5:487MG/DL (B)(6) 2016 04:16:00 AM FASTING:YES, MEMORY CONCERNS:271,426,502,278,487MG/DL.. CUSTOMER BELIEVED HER RESULTS ARE INCONSISTENT BECAUSE HER METER REGISTERS HIGHER THAN ANOTHER DEVICE THEY COMPARED TO. OTHER DEVICE 331 TRUETRACK 445MG/DL. RAN BLOOD TEST WHILE TROUBLESHOOTING 338MG/DL (NON FASTING)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134402 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4546

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR