BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1021767 · Received March 20, 2008

    Report

    Report Number
    1823260-2008-02593
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    March 8, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS BACK TO BACK TESTING ON METER TO LAB WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 132 MG/DL ON THE METER AND 34 MG/DL AT THE LAB. REPORTER REPORTS L1 AND L2 QUALITY CONTROLS WERE RUN AND IN RANGE. REPORTER REPORTS THE PATIENT WAS TREATED WITH DEXTROSE D50 A&P. REPORTER STATES THERE ARE NO KNOWN ISSUES IN TERMS OF THE PATIENT'S CONDITION; PATIENT IS NO LONGER AT THE HOSPITAL. 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 550513

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOVOLOG SLIDING SCALE| DOXAZOSIN 2 MG/DAY| LIPITOR 20 MG/DAY| DEXTROSE D50 A&P AS NEEDED| PRILOSEC 20 MG/DAY