BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2441121 · Received February 7, 2012

    Report

    Report Number
    1823260-2012-00690
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 7, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WAS NOT ABLE TO OBTAIN THIS INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 680 MG/DL AND 130 MG/DL, 440 MG/DL AND 113 MG/DL. THE RESULT OF 680 MG/DL IS OUTSIDE THE NUMERIC RANGE OF 10-600 MG/DL OF THE DEVICE. THE COMPARISONS WERE OBTAINED AT DIFFERENT INTERVALS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1