BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083776 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05769
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    March 26, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE SUSPECT DEVICE USED IN INFO SYSTEM WITH PATIENT #3. PLEASE SEE MEDWATCH FOR SUSPECT DEVICE IN INFORM SYSTEM WITH PATIENT #1.

    Description of Event or Problem · 1

    CALLER REPORTS ON PT #3 METER COMPARISON TO LAB WITH RESULTS OF 531MG/DL ON THE METER AND 213MG/DL AT THE LAB WHILE USING THE INFORM SYSTEM. CALLER REPORTS NO TREATMENT WAS REC'D BASED ON METER RESULTS AND SYMPTOMS WERE UNKNOWN. CALLER REPORTS PT WAS ADMITTED FOR ANEMIA. CALLER REPORTS QUALITY CONTROLS WERE ON LOCKOUT; CONTROLS WERE IN RANGE. NO ADVERSE EVENT WAS REPORTED. CALLER REPORTS STRIPS HAVE BEEN USED AND NO PRODUCT TO RETURN; A REPLACEMENT 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 549912

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR