BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1011736 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02316
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE SUSPECT DEVICE USED IN INFORM SYSTEM #2. PLEASE SEE MEDWATCH WITH A1 PATIENT FOR SUSPECT DEVICE IN INFORM SYSTEM #1.

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK RESULTS OF 196 MG/DL ON INFORM SYSTEM #2 COMPARED TO RESULTS OF 406 MG/DL ON INFORM SYSTEM #1. CALLER REPORTS 2 DIFFERENT STRIP VIALS WERE USED WITH THE SAME STRIP LOT NUMBER. NO QUALITY CONTROL INFORMATION WAS PROVIDED. 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 549822

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK