BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4942259 · Received July 23, 2015

    Report

    Report Number
    1052693-2015-01211
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 20, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LO BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 92 TO 120MG/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 NOT TAKING MEDICATION TO MANAGE DIABETES. BLOOD TEST PERFORMED NON-FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULT OF LO. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: LO, (B)(6) 2015, 10:05PM; LO, (B)(6) 2015, 09:58PM; LO, (B)(6) 2015, 09:55PM; LO, (B)(6) 2015, 09:52PM; LO, (B)(6) 2015, 09:52PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479461 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PP1616

    Patients

    Seq Age Sex Outcome Treatment
    1