BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5325773 · Received December 23, 2015

    Report

    Report Number
    1052693-2015-02564
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    November 30, 2015
    Report Date
    December 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. MS. MAE CAREGIVER CALLING ON BEHALF OF CUSTOMER. CAREGIVER STATES THE CUSTOMER WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 95-105MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 9/26/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN PROPERLY STORED AND WERE FIRST OPENED 11/4/2015. REVIEWED METER MEMORY: (B)(6). CUSTOMER IS CONCERNED WITH RESULT OF 66 MG /DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848703 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2513

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR