BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2962087 · Received February 14, 2013

    Report

    Report Number
    1823260-2013-00890
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    April 8, 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).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULT OF 87 MG/DL ON THE COMPACT PLUS SYSTEM, AND RESULT OF 51 MG/DL ON A PROFESSIONAL DEVICE WITHIN 10 MINUTES. 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
    64920 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208048

    Patients

    Seq Age Sex Outcome Treatment
    1 090 YR