BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK

    MDR report key: 3252482 · Received July 24, 2013

    Report

    Report Number
    1052693-2013-00145
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 24, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. METER MEMORY: 234MG/DL (FASTING), 184MG/DL (FASTING), 333 MG/DL (EVENING AFTER EATING), 124MG/DL (FASTING), 587MG/DL (EVENING AFTER EATING). CALLER STATES NORMAL RESULTS SHOULD BE 120-130 MG/DL FASTING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345191 SIDEKICK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. SIDEKICK SN3820

    Patients

    Seq Age Sex Outcome Treatment
    1