BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAZZ BGMS

    MDR report key: 2576211 · Received May 10, 2012

    Report

    Report Number
    3004637226-2012-00022
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 3, 2012
    Report Date
    May 10, 2012
    Manufacturer
    AGAMATRIX INC.
    Product Code
    NBW
    PMA / PMN Number
    K072413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS RETURNED AND TESTED PER AGAMATRIX PROCEDURES. NO FAULT WAS FOUND WITH METER. CUSTOMER DID NOT SUFFER HARM DUE TO INCIDENT. THIS CASE HAS BEEN CLOSED.

    Description of Event or Problem · 1

    CUSTOMER STATES HIS JAZZ METER WAS READING HIGHER AS COMPARED TO THE ONE TOUCH METERS HE WAS PREVIOUSLY USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAZZ BGMS BLOOD GLUCOSE METER NBW AGAMATRIX INC. 8000-02345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other