BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4874076 · Received June 25, 2015

    Report

    Report Number
    1052693-2015-00984
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 24, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION: NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: USER'S TEST STRIP HAD POOR STORAGE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 100 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 122 MG/DL AND 116 MG/DL. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS NOT VERIFIED. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410873 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2213

    Patients

    Seq Age Sex Outcome Treatment
    1