BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1191528 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07207
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 112 MG/DL BACK TO BACK WITH A RESULT OF 210 MG/DL ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. 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 CORP. 20679841

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR OYSCO| THEOPHYLLINE - "300MG"| CLARITIN D - YEARS| MYDROCODONE - 1 MONTH| VEGRID| METFORMIN -500MG TWICE DAILY| SEROQUEL - YEARS