BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1823623 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05214
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM (LOT NUMBER 20726910, EXPIRATION DATE 09/30/2011). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 507 MG/DL, 427 MG/DL, AND 385 MG/DL. A RESULT OF 110 MG/DL WAS OBTAINED ON CUSTOMER'S COMPACT PLUS SYSTEM WITHIN 10 MINUTES OF THE REPORTED RESULTS. 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 20726910

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR