BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052292 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04287
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 550615, EXPIRATION DATE 07/31/2009). REFERENCE MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF HI (GREATER THAN 600 MG/DL) ON A PATIENT USING INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 198 MG/DL ON THE SAME PATIENT USING INFORM SYSTEM 2 WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550615

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR 70/30 INSULIN