BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4824633 · Received June 4, 2015

    Report

    Report Number
    1052693-2015-00856
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 9, 2015
    Report Date
    June 4, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 LOW BLOOD RESULTS AND LOW CONTROL RESULTS. EXPECTED FASTING BLOOD RESULT RANGE IS 70 TO 140 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. BACK DECLINED. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/13/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:23MG/DL, (B)(6) 2015, 11:30 AM . 2:25MG/DL, (B)(6) 2015, 11:19 AM. 3:36MG/DL, (B)(6) 2015, 12:38 PM. 4:22MG/DL, (B)(6) 2015, 11:44 AM. 5:23MG/DL, (B)(6) 2015, 11:30 AM . ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363557 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR2068

    Patients

    Seq Age Sex Outcome Treatment
    1