BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1885231 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06404
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 24, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER HAS ALLEGED THAT THE LANCET PROTRUDES PAST THE OPENING OF A SAFE-T-PRO PLUS SINGLE USE DEVICE. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT SYSTEM WITHIN 10 MINUTES: 292 MG/DL, 128 MG/DL, AND 113 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS; 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 20726543

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR PACEMAKER| LEVOTHROID| LANTUS| LANOXIN| WARFARIN| LORAZEPAM| VERAPAMIL| ACTOS