BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4924401 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01201
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 16, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVAL. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: IMPROPER STORAGE OF TEST STRIPS AS INDICATED BY CUSTOMER.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120 MG/DL. 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. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPEC SINCE THEY ARE KEPT IN KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/22/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1: 106 MG/DL, (B)(6) 2015, 03:43 PM; 2: 66 MG/DL, (B)(6) 2015, 03:22 PM; 3: 63 MG/DL, (B)(6) 2015, 03:18 PM; 4: 111 MG/DL, (B)(6) 2015, 07:03 AM; 5: 122 MG/DL, (B)(6) 2015, 08:06 PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463678 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR2173

    Patients

    Seq Age Sex Outcome Treatment
    1