BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 833299 · Received February 13, 2007

    Report

    Report Number
    1823260-2007-01290
    Event Type
    Malfunction
    Date Received
    February 13, 2007
    Date of Event
    January 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT PRODUCT IS THE COMFORT CURVE STRIPS. THE CUSTOMER NO LONGER HAS THE STRIPS, SO THEY WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    PT REPORTED OBTAINING RESULTS THAT WERE OUTSIDE THE SYSTEM'S MEASUREMENT RANGE OF 10 TO 600 MG/DL. HE STATES HE OBTAINED BG READINGS OF 000, 666, 800, AND 900 MG/DL. THESE RESULTS WERE OBTAINED USING THE COMPLETE SYSTEM (METER, STRIP LOT UNKNOWN, CATALOG NUMBER 2030373). 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 SYSTEM. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT, ALTHOUGH THE CUSTOMER INDICATED HE NO LONGER HAS THE PRODUCTS, BUT 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 * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR 70/30 INSULIN, VARIES/VARIES