BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 2161851 · Received July 14, 2011

    Report

    Report Number
    1823260-2011-03738
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 12, 2011
    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). MEDWATCH WITH IDENTIFIER (B)(4) IS FOR MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 586 MG/DL ON CUSTOMER'S MOBILE SYSTEM, 138 MG/DL ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METERS AND STRIPS.

    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 208017

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR HUMALOG 3XDAY