BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2111343 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02928
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 SYSTEM 1 (LOT NUMBER 20800542, EXPIRATION DATE 03/31/2012). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULTS OF 31.0 MMOL/L ON COMPACT PLUS SYSTEM 1 AND 11.0 MMOL/L ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. ON A DIFFERENT DATE CUSTOMER TESTED 29.0 MMOL/L ON COMPACT PLUS SYSTEM 1 AND 9.7 MMOL/L ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. HIGH BLOOD GLUCOSE SYMPTOMS WERE REPORTED DURING THIS COMPARISON. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    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 20800542

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR APIDRA 3 TIMES DAILY| LANTUS 3 TIMES DAILY| "RAPEL" ONCE DAILY