BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5014639 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01393
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 15, 2015
    Report Date
    August 10, 2015
    Manufacturer
    NIPRODIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HI BLOOD GLUCOSE TEST RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 186 TO 350 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015 AS A RESULT OF THE METER'S READINGS. CURRENTLY TAKING MEDICATION AND INSULIN TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/28/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: HI (B)(6) 2015 02:35 AM; 377 MG/DL (B)(6) 2015 04:00 AM; HI (B)(6) 2015 10:00 AM; HI (B)(6) 2015 08/:00 AM; HI (B)(6) 2015 04:30 AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533076 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRODIAGNOSTICS, INC. TRUERESULT PR2050

    Patients

    Seq Age Sex Outcome Treatment
    1