BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1976119 · Received February 1, 2011

    Report

    Report Number
    1823260-2011-00532
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 16, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS FOR 2 PATIENT SAMPLES WHEN TESTING WITH THE TROPONIN I STAT (TNI) APPLICATION ON THE ELECSYS SYSTEM. REPEAT TESTING WAS PERFORMED ON THE SAME ANALYZER. FOR PATIENT 1, THE INITIAL TNI RESULT WAS 0.364 NG/ML WITH A DATA FLAG. REPEAT TESTING YIELDED A TNI OF < 0.300 NG/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. FOR PATIENT 2, DATE OF BIRTH 06/24/1931, THE INITIAL TNI RESULT WAS 0.576 NG/ML. REPEAT TESTING YIELDED A TNI OF < 0.300 NG/ML. THE INITIAL TNI WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE TNI REAGENT LOT NUMBER WAS 15779101. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY A FAULTY MEASURING CELL. HE REPLACED THE CELL AND ALSO REPLACED A CPU BATTERY. PERFORMANCE TESTING, CALIBRATION, AND QUALITY CONTROLS ALL PERFORMED WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 092 YR