BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4451478 · Received January 22, 2015

    Report

    Report Number
    1052693-2015-00049
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 28, 2014
    Report Date
    January 9, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". REVIEWED THE LAST 5 BLOOD RESULTS IN THE METER MEMORY: 1) LO, (B)(6), 11:23 AM, BEFORE EATING 2) LO, (B)(6) 10:30 PM, + 2 HOURS AFTER EATING 3) LO, (B)(6) 10:20 PM (ANOTHER PERSON) 4) LO, (B)(6) 11:37 PM, +2 HOURS AFTER EATING 5) LO (B)(6) 11:41 PM, +2 HOURS AFTER EATING NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52946 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1959

    Patients

    Seq Age Sex Outcome Treatment
    1