BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1061148 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04726
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT ANOTHER COMPARATIVE TEST OF 262 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 80 MG/DL WITHIN 10 MINUTES ON A NEONATE USING INFORM SYSTEM 2. 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. REPORTER STATED THAT THE STRIPS WERE ALL USED, AND SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 550549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK