BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4908402 · Received July 9, 2015

    Report

    Report Number
    1052693-2015-01106
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET EVALUATED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 135 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPEC SINCE THEY ARE KEPT IN DINING AREA. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/30/2016 AND OPEN VIAL DATE IS 1 TO 2 WEEKS. RECALL TEST RESULTS PERFORMED FROM METER MEMORY (DATE / TIME NOT SET): 1: 81 MG/DL (B)(6) 2014 10:57PM FASTING: YES, 2: 59 MG/DL (B)(6) 2014 10:51PM FASTING: YES, 3: 62 MG/DL (B)(6) 2014 08:21PM FASTING: NO, 4: 62 MG/DL (B)(6) 2014 02:33PM FASTING: YES, 5: 60 MG/DL (B)(6) 2014 02:50PM FASTING: YES. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445201 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PP1493

    Patients

    Seq Age Sex Outcome Treatment
    1