BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002639 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01351
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 8, 2008
    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 STATED THAT BACK TO BACK TESTING WAS PERFORMED ON THE INFORM SYSTEM AND A LAB INSTRUMENT WITH RESULTS OF 19 MG/DL ON THE INFORM AND 167 MG/DL AT THE LAB. NO QUALITY CONTROL INFO WAS PROVIDED. PT WAS GIVEN D50; APPLICATION INTERVAL OR AMOUNT GIVEN WAS NOT PROVIDED. PT IS IN THE ICU; STATUS NOT PROVIDED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT 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 550082

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK