BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1924235 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07417
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 1, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED FOR COMPACT PLUS SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS SYSTEM 1 BLOOD GLUCOSE RESULT OF 0.6 MMOL/L AND 6.0 MMOL/L ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. NO INFORMATION WAS PROVIDED FOR COMPACT PLUS SYSTEM 2. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER 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 207273

    Patients

    Seq Age Sex Outcome Treatment
    1 015 YR ACTRAPID 2XDAY| LEVEMIR 1XDAY| NOVORAPID