BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 868586 · Received February 15, 2007

    Report

    Report Number
    1823260-2007-01358
    Event Type
    Malfunction
    Date Received
    February 15, 2007
    Date of Event
    January 12, 2007
    Report Date
    February 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMFORT CURVE TEST STRIPS (CAT NO. 2030381, LOT N. 549306 WITH EXPIRATION DATE 12/31/2007) ARE THE SUSPECT PRODUCT.

    Description of Event or Problem · 1

    PT REPORTED OBTAINING BACK-TO-BACK BLOOD GLUCOSE RESULTS OF APPROX 100 MG/DL AND APPROX 200 MG/DL (PT COULD NOT RECALL EXACT VALUES), ON THE ADVANTAGE SYSTEM (STRIP LOT 549306 WITH EXPIRATION DATE 12/31/2007). PT DID NOT MODIFY THERAPY BASED ON THESE RESULTS. NO PT INJURY WAS REPORTED AND NO TREATMENT WAS RECEIVED. PT DID NOT PROVIDE THE LOCATION WHERE THE DISCREPANT RESULTS WERE OBTAINED. QUALITY CONTROL TESTING HAD NOT BEEN PERFORMED ON THE SUSPECT DEVICE. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    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 * 549306

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR TOPROL XL 50 MG| CHROMIUM| PRAVASTATIN 80 MG| ASPIRIN 81 MG| GLYBURIDE 2.5 MG| FUROSEMIDE 40 MG| LISINOPRIL 40 MG