BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4942252 · Received July 23, 2015

    Report

    Report Number
    1052693-2015-01247
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. INTERNAL REPORT (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S IS UNSURE WHAT HER EXPECTED BLOOD RESULTS SHOULD BE. VERIFIED THE STRIPS EXPIRE 05/18/2015. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BLOOD TEST, 303MG/DL FASTING. REVIEWED METER MEMORY: 310MG/DL, (B)(6) 2015, 09:20:00 AM, FASTING: YES; 307MG/DL, (B)(6) 2015, 09:15:00 AM, FASTING: YES; 288MG/DL, (B)(6) 2015, 09:13:00 AM, FASTING: YES; 273MG/DL, (B)(6) 2015, 09:08:00 AM, FASTING: YES. WHEN METER MEMORY WAS REVIEWED "LO" WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479454 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PS2320

    Patients

    Seq Age Sex Outcome Treatment
    1