BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1974137 · Received January 31, 2011

    Report

    Report Number
    1823260-2011-00516
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS ON ONE PATIENT SAMPLE FOR THE HUMAN CHORIONIC GONADOTROPIN, STAT (SHORT TURN AROUND TIME) - (HCG) APPLICATION ON THE COBAS E411 DISK SYSTEM. INITIAL AND REPEAT TESTING WERE PERFORMED ON THE SAME ANALYZER. THE INITIAL HCG RESULT WAS > 10,000 MIU/ML WITH A DATA FLAG. THE ASSAY WAS RERUN AT A 1:100 DILUTION PERFORMED BY THE ANALYZER. THE RESULT WAS 149.3 MIU/ML WITH A DATA FLAG. THE CUSTOMER THEN PERFORMED A MANUAL 1:100 DILUTION AND OBTAINED A RESULT OF 9360 MIU/ML, WHICH WAS CONSIDERED TO BE THE CORRECT RESULT AND REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT AS NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE HCG REAGENT LOT NUMBER WAS 15851601. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY A DEFECTIVE MEASURING CELL. HE REPLACED THE CELL. THE OPERATOR PERFORMED CALIBRATION AND QUALITY CONTROLS, WHICH MET SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1