BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2063663 · Received April 20, 2011

    Report

    Report Number
    1823260-2011-02134
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TROPONIN T STAT, CARDIAC T (TNT) RESULTS FOR ONE PATIENT SAMPLE WHICH WAS COLLECTED "IN EMERGENCY". THE REPEAT RESULTS WERE GENERATED FROM THE SAME ANALYZER. THE INITIAL RESULT WAS <0.010 UG/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED AND RECOVERED 0.232 UG/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED AGAIN AND RECOVERED <0.010 UG/L. THE <0.010 UG/L RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT HARMED. THE TNT REAGENT LOT NUMBER WAS NOT PROVIDED. THE QUALITY CONTROL PRIOR TO AND AFTER THE EVENT EXHIBITED NO ISSUE AND THE MESSAGE HISTORY CONTAINED NO HINT OF THE POSSIBLE ROOT CAUSE. THE FIELD SERVICE REPRESENTATIVE HAD REPLACED THE THE MEASURING CELL ON (B)(6) 2011 AT WHICH TIME PERFORMANCE TESTS WERE WITHIN SPECIFICATION. THE ROOT CAUSE OF THE ISSUE WAS NOT DETERMINED. THE INVESTIGATION FOUND A POSSIBLE ROOT CAUSE WAS TOO SHORT CLOTTING TIME OF THE SAMPLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1