BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 RACK ELECSYS

    MDR report key: 1780193 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08261
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. SAMPLE FROM (B)(6) 2007, INITIAL RESULT 0.013 NG/ML, REPEAT 0.125 NG/ML. SAMPLE FROM (B)(6) 2007, INITIAL RESULT 0.01 NG/ML, REPEAT 0.125 NG/ML. A NEW SAMPLE WAS ALSO TESTED ON (B)(6) 2007 AND GAVE INITIAL RESULT OF 0.02 NG/ML, REPEAT 0.126 NG/ML. INITIAL RESULTS WERE REPORTED, PTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE PROBE WAS OUT OF ALIGNMENT AND A BELT WAS LOOSE. THE INSTRUMENT WAS REPAIRED.

    Description of Event or Problem · 2

    TWO PT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. PT 2, SAMPLE FROM (B)(6) 2007, INITIAL RESULT<0.01 NG/ML, REPEAT 0.395 NG/ML. SAME SAMPLE REPEATED ON DIFFERENT INSTRUMENT, SAME METHOD, GAVE RESULT OF 0.411 NG/ML. INITIAL RESULTS WERE REPORTED, PTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE PROBE WAS OUT OF ALIGNMENT AND A BELT WAS LOOSE. THE INSTRUMENT WAS REPAIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR
    2 85 YR