BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1801391 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04832
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    March 6, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE FOLLOWING COMPACT PLUS SYSTEM/LAB VALUES WITHIN 10 MINUTES: 75 MG/DL/30 MG/DL, 180 MG/DL/90 MG/DL THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR HUMULIN N| HUMALOG| HUMULIN R