BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4561974 · Received February 26, 2015

    Report

    Report Number
    1052693-2015-00211
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 26, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT #: (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". I THEN HAD HER RUN A BACK TO BACK BLOOD TEST, HI AND HI. HER EXPECTED BLOOD RANGE IS 140MG/DL-150MG/DL AND IN THE MORNING SHOULD RANGE FROM 80-95MG/DL. MEMORY RESULTS WERE (TIME AND DATE WERE INCORRECT). HI-(B)(6) 11:18PM. HI-(B)(6)-11:09PM. HI-(B)(6)-10:40PM. HI-(B)(6)-10:36PM. HI-(B)(6)-10:34PM. CUSTOMER HAD BEEN STORING THE SUPPLIES PROPERLY AT ROOM TEMPERATURE. SHE STATED THAT WAS NOT FEELING WELL. I ADVISED HER TO STOP USING THE PRODUCT AND SEEK MEDICAL ATTENTION, WHICH SHE WILL DO. CUSTOMER WAS LATER CONTACTED, SHE STATED SHE HAD SEEN HER DOCTOR (B)(6) 2015 AND THEY WERE ABLE TO CONFIRM THAT METER WAS TESTING ACCURATELY. THEY TOOK BLOOD TEST, RESULTS READ AT 588MG/DL AT THE DOCTOR'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137349 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR1809

    Patients

    Seq Age Sex Outcome Treatment
    1 Other