BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780405 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08068
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 26, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 549730, EXPIRATION DATE 08/31/2008). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED A PATIENT WHO RECEIVED RESULTS OF HI (GREATER THAN 600 MG/DL) AND 118MG/DL WITHIN 10 MINUTES ON THE INFORM SYSTEM. CUSTOMER DID NOT KNOW WHICH SYSTEM PRODUCED THE DISCREPANT RESULTS. CUSTOMER REPORTS A SECOND PATIENT WHO REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON INFORM SYSTEM 1: 49 MG/DL, 164 MG/DL, 92 MG/DL, AND 26 MG/DL. A RESULT OF HI WAS OBTAINED ON INFORM SYSTEM 2 WITHIN 10 MINUTES ON THE RESULTS OF 26 MG/DL. A LAB VALUE WAS DRAWN WITHIN 10 MINUTES OF THE RESULTS OF HI AND 26 MG/DL: LAB RESULT WAS <10 MG/DL. NO ACTIONS TAKEN BASED ON THE DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 549730

    Patients

    Seq Age Sex Outcome Treatment
    1 NA