BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1792114 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04731
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 1) 400 MG/DL, 300 MG/DL, 188 MG/DL, AND 200 MG/DL 2) 224 MG/DL, 425 MG/DL, 188 MG/DL, 170 MG/DL, AND 186 MG/DL SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS. NO ACTIONS TAKEN BASED ON 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 ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20725747

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DIABETES MEDICATION 1X DAILY