BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1832652 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05408
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 808:02, WHICH OCCURRED ON CHANNEL A. ACCORDING TO THE FACILITY, THIS EVENT OCCURRED IN THE CRITICAL CARE UNIT. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULT OF 300 MG/DL, PROFESSIONAL SYSTEM RESULT OF 121 MG/DL AT THE SAME TIME. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 20726646

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR NOVOLOG| LANTUS| ASPIRIN