BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1935296 · Received December 22, 2010

    Report

    Report Number
    1823260-2010-07623
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 9, 2010
    Report Date
    January 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    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

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. BASED UPON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THE EVENT WAS A PRE-ANALYTICAL SAMPLE HANDLING ISSUE. THE CUSTOMER WAS CENTRIFUGING THEIR SAMPLE TUBES FOR 10 MINUTES. THE TUBE MANUFACTURER RECOMMENDATION IS 15 MINUTES FOR THE TYPE OF SAMPLE TUBE IN USE. QUALITY CONTROLS PERFORMED PRIOR TO AND AFTER THE SAMPLE WAS TESTED WERE ACCEPTABLE. ASSAY PERFORMANCE TESTS PERFORMED ON THE ANALYZER WERE WITHIN SPECIFICATION. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TROPONIN T STAT, CARDIAC T (TROPONIN T STAT) RESULTS FOR ONE PATIENT SAMPLE FROM THE EMERGENCY ROOM. THE INITIAL RESULT WAS 0.156 UG/L. THE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. LABORATORY PROTOCOL DICTATES THAT THEY REPEAT ALL NEW POSITIVE TROPONIN T STAT RESULTS FROM PATIENTS THAT DO NOT HAVE RECENT TROPONIN T STAT RESULTS. THE SAMPLE WAS REPEATED TWICE ON THE SAME ANALYZER AND RECOVERED <0.010 UG/L BOTH TIMES. THE <0.010 UG/L RESULT WAS CONSIDERED THE CORRECT RESULT AND WAS REPORTED OUTSIDE THE LABORATORY AND TO THE PHYSICIAN. THE SAMPLE INTEGRITY IS SUSPECTED BECAUSE THE CENTRIFUGED PRIMARY SERUM SAMPLE WITH GEL TUBE DID HAVE VISIBLE FLOATING DEBRIS AFTER THE SAMPLE WAS GENTLY RE-SUSPENDED/MIXED. THE REAGENT LOT NUMBER WAS 15887701.

    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