BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1061147 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04725
    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

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 550549, EXPIRATION DATE 07/31/2009). REFERENCE MEDWATCH REPORT FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 25 MG/DL AND 38 MG/DL ON THE INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 41 MG/DL ON THE INFORM SYSTEM 2 WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART ON A NEONATE. 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