BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 800545 · Received December 22, 2006

    Report

    Report Number
    1823260-2006-07729
    Event Type
    Malfunction
    Date Received
    December 22, 2006
    Date of Event
    October 21, 2006
    Report Date
    December 22, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE MEASURED 300 MG/DL HOWEVER, CUSTOMER HAD NO SYMPTOMS AT THE TIME. CUSTOMER STATED RETESTING AS A RESULT AND METER YIELDED MEASUREMENTS OF 213, 141 & 109 MG/DL WHEN ALL TESTS WERE PERFORMED BACK TO BACK WITHIN 10 MINUTES. NO ACTIONS WERE TAKEN OR TREATMENT RECEIVED REPORTEDLY AS A RESULT. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR METHOTRIXATE 6 YEARS 5 MG 1XWEEK (5 PILLS)| BLOOD PRESSURE MED 4-5 YEARS 400MG/ 1XDAY| IMBREL 6 YEARS 50 MG 1XWEEK