BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1221603 · Received August 19, 2008

    Report

    Report Number
    1823260-2008-06306
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 550055, EXPIRATION DATE 03/31/2009). REFERENCE MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 308 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 128 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. 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 550055

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR METFORMIN 500 MG TWICE DAILY| GLIPIZIDE 10 MG DAILY| LANTUS 18 UNITS DAILY