BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2011517 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01259
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ISSUE WITH CALIBRATION AND NON-ROCHE QUALITY CONTROL FOR THE TROPONIN T STAT GENERATION 4 (TNT) ASSAY SINCE (B)(6) 2011. THE USER PULLED PREVIOUSLY TESTED PATIENT SAMPLES AND RAN THEM ON THE ELECSYS 2010 ANALYZER SERIAL NUMBER (B)(4) AND THEN ON ELECSYS 2010 ANALYZER SERIAL NUMBER (B)(4) TO PERFORM A COMPARISON STUDY USING PATIENT SAMPLES. THE RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL RESULT WAS 0.27 NG/ML AND THE REPEAT RESULT WAS 0.39 NG/ML. PATIENT SAMPLE 2 INITIAL RESULT WAS 0.43 NG/ML AND THE REPEAT RESULT WAS 0.52 NG/ML. THE USER STATED SHE DID NOT FEEL ANY ERRONEOUS RESULTS HAD BEEN REPORTED OUTSIDE THE LABORATORY. NO PATIENTS WERE ADVERSELY AFFECTED. THE TNT REAGENT LOT NUMBER WAS 15989401. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE RAN PERFORMANCE TESTING WHICH WAS WITHIN SPECIFICATION. THE INVESTIGATION DETERMINED THE NON-ROCHE QUALITY CONTROL MATERIAL WAS NOT SUITABLE FOR THE ELECSYS TNT GEN. 4 ASSAY AS NO TARGET VALUES COULD BE DETERMINED DUE TO HIGH COEFFICIENT'S OF VARIABILITY OBSERVED IN THE MEASUREMENTS.

    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