BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1170816 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06904
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE SUSPECT DEVICE USED IN ADVANTAGE SYSTEM #1. PLEASE SEE MEDWATCH WITH A1 PT FOR SUSPECT DEVICE IN ADVANTAGE SYSTEM A2.

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK RESULTS OF 302MG/DL ON ADVANTAGE SYSTEM #1 COMPARED TO RESULTS OF 89MG/DL ON ADVANTAGE SYSTEM #2. CALLER REPORTS L1 AND L2 QUALITY CONTROLS WERE RUN PRIOR TO THE CALL AND OUT OF RANGE ON SYSTEM #1. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND 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 550632

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR BISOPROLOL ABOUT 6 MONTHS| OXYCODONE - 2-3 YRS| TRAZODONE - "A NUMBER OF YRS"| ZOCOR - "A NUMBER OF YRS"| CAPTOPRIL - ABOUT 2 YRS| LEVOTHYROXINE - OVER 1 YR| GLYBURIDE 2-3 YRS| MEXITIL ABOUT 6 MONTHS| CELEXA - UNK| ASPIRIN -"A NUMBER OF YRS"| FUROSEMIDE - "A NUMBER OF YRS"| PREDNISONE - ABOUT 3 YRS| POTASSIUM -"A NUMBER OF YRS"| SPIRONOLACTONE - 6 MONTHS TO A YR