BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2946331 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00729
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 20805146, EXPIRATION DATE 06/30/2013). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULTS OF 109 MG/DL AND 59 MG/DL ON THE AVIVA COMBO SYSTEM, AND RESULTS OF 54 MG/DL AND 59 MG/DL ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. 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
    50868 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20805146

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR