BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1022675 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02900
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT THE FOLLOWING DISCREPANT BACK-TO-BACK BLOOD GLUCOSE RESULTS WERE OBTAINED WHILE USING THE COMPACT PLUS SYSTEM: 20 MG/DL AND 175 MG/DL, 20MG/DL AND 155 MG/DL, 21 MG/DL, 20 MG/DL, AND 134 MG/DL, 21 MG/DL AND 138 MG/DL, 20 MG/DL AND 89 MG/DL, 18 MG/DL AND 89 MG/DL, 19 MG/DL AND 185 MG/DL, 21 MG/DL AND 132 MG/DL, 216 MG/DL AND 83 MG/DL. REPORTER DID NOT INDICATE IF ANY PATIENT'S THERAPY WAS MODIFIED BASED ON THESE VALUES. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - NA LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK