BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1311071 · Received February 2, 2009

    Report

    Report Number
    1823260-2009-00779
    Event Type
    Malfunction
    Date Received
    February 2, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 2, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT # 550023, EXPIRATION DATE 02/28/2009). REFERENCE MEDWATCH REPORT WITH A1 PT FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE READINGS OF 149 MG/DL AND 63 MG/DL ON A PT USING ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 142 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP. 550023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK