BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1110266 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05221
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 30, 2007
    Report Date
    June 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DISCREPANT BACK TO BACK PT BLOOD GLUCOSE RESULTS OF 456 MG/DL AT 3:33 AM ON THE INFORM SYSTEM COMPARED TO A LAB THAT WAS DRAWN AT 3:35 AM WHICH PRODUCED A MEASUREMENT OF 76 MG/DL. REPORTER INDICATED THE PT DID NOT RECEIVE ANY TREATMENT AND NO OTHER ACTIONS WERE TAKEN BASED ON THE RESULTS. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549533

    Patients

    Seq Age Sex Outcome Treatment
    1