BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1041203 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03892
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 6, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 38 MG/DL BACK TO BACK WITH A RESULT OF 193 MG/DL ON A PT USING THE INFORM SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINS APART. REPORTER STATED THAT THE PT HAD JUST BEEN ADMITTED WITH SYNCOPE AND RESPIRATORY FAILURE. REPORTER STATED THAT THE PT WAS INTUBATED IN BETWEEN THE BACK TO BACK RESULTS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. REPORTER STATED THAT ROUTINE CONTROLS WERE RUN OR ON THE SYSTEM AND WITHIN RANGE. 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 CORP. 550514

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR