BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1070493 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05243
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    July 1, 2007
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE VALUE IN THE 100-199 MG/DL RANGE BACK TO BACK WITH A RESULT OF 200-299 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER STATED THAT AT A DIFFERENT TIME ANOTHER COMPARATIVE TEST OF 300 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 112 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 69 YR ACTOS - SEVERAL YEARS 10MG DAILY