BEUDAMED
    FDA Adverse Event Other Summary report: N

    JAZZ BGMS

    MDR report key: 2881400 · Received December 18, 2012

    Report

    Report Number
    3004637226-2012-00043
    Event Type
    Other
    Date Received
    December 18, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 17, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K072413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    PT ATTENDING CLINIC APPOINTMENT - RANDOM BLOOD GLUCOSE ASSAYED ON YSI - RESULT 2.7MMOL/L (3.0 PLASMA EQUIVALENT). PT SURPRISED AS HIS RESULT WAS 6.9 ON JAZZ METER PRIOR TO DRIVING TO CLINIC APPROX 30 MINS AGO. PT ASKED TO BRING METER INTO CLINIC FOR CHECKING. ON (B)(6) 2012: METER COMPARISON DONE BY DIABETES CENTER: YSI RANDOM BLOOD GLUCOSE 6.8 MMOL/L (PLASMA EQUIVALENT 7.6) JAZZ RESULT 10.4MMOL/L. PT TECHNIQUE IN PERFORMING TEST ON METER OBSERVED AND WAS CORRECT. IT WAS INDICATED BY THE DIABETES CENTER DOING THE TESTING THAT NO INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAZZ BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-02345 JM22WS41G

    Patients

    Seq Age Sex Outcome Treatment
    1