BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5221527 · Received November 13, 2015

    Report

    Report Number
    1052693-2015-02195
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 13, 2015
    Report Date
    November 12, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: USER HAD AN INACCURATE REFERENCE, USER'S TEST STRIP HAD POOR FILL. NO ADDITIONAL INFORMATION OBTAINED, THE MANUFACTURER WE WILL CONTINUE TO TRY AND CONTACT THE COMPLAINANT FOR ADDITIONAL INFORMATION, THIS IS THE INFORMATION AVAILABLE AT THIS POINT.

    Description of Event or Problem · 1

    (B)(6) EMAILED MANUFACTURER'S REGIONAL MANAGER OF NIPRO DIAGNOSTICS, INC WITH THE FOLLOWING COMPLAINT: PRODUCT COMPLAINT FOR THE TRUERESULT MONITORS READING ANYWHERE FROM 20-30 POINTS HIGH OR LOW. THE MALE PATIENT ENDED UP GOING TO THE EMERGENCY ROOM (E.R.) AND WAS ADMITTED FOR 2 DAYS. HE WAS THEN DISCHARGED, AND AS FAR AS (B)(6) KNOWS HE IS DOING FINE. HE DOES NOT RETURN HER PHONE CALLS. SHE DID SET HIM UP WITH ANOTHER NDI METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752046 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY