BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4908391 · Received July 9, 2015

    Report

    Report Number
    1052693-2015-01130
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 9, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S MISUNDERSTANDING OR ERRATIC RESULTS.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 110 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME OF THE CALL ON (B)(6) 2015. STORAGE OF PRODUCT IS NOT VERIFIED. TEST STRIP LOT MFR'S EXPIRATION DATE IS 03/13/2018 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (DATE/ TIME NOT SET): 117MG/DL (B)(6) 2015 07:00PM; 107MG/DL (B)(6) 2015 07:40AM; 194MG/DL (B)(6) 2015 07:23AM; 112MG/DL (B)(6) 2015 07:15PM; 138MG/DL (B)(6) 2015 06:21PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445153 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PS2242

    Patients

    Seq Age Sex Outcome Treatment
    1