BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1000697 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01604
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    MULTIPLE PTS WITH DISCREPANT RESULTS FOR MULTIPLE TESTS. THE FOLLOWING EXAMPLES WERE PROVIDED. SAMPLE #, TEST NAME, ORIGINAL RESULT/REPEAT RESULT/UNITS. CKMB 1.93/2.46 NG/ML. TNT 0.138/0.203 NG/ML. CKMB 1.08/3.36 NG/ML. CKMB <0.10/1.96 NG/ML. MYO <21/25.78 NG/ML. CKMB 3.69/14.8 NG/ML. CKMB 0.592/3.59 NG/ML. CKMB <0.100/1.98 NG/ML. CKMB 0.387/2.83 NG/ML. TNT 0.032/0.177 NG/ML. CKMB 0.64/2.75 NG/ML. CKMB 0.365/2.51 NG/ML. DIG 3.72/0.878 NG/ML. CKMB 0.646/3.23 NG/ML. CKMB 4.53/16.92/17.25 NG/ML. DIG >5.0/1.15 NG/ML. TSH 0.912/2.52 ULU/ML. TNT <0.010/0.162 NG./ML. CKMB 0.776/4.16 NG/ML. TNT 0.645/3.41 NG/ML. CKMB 0.882/4.03 NG/ML. CKMB 1.26/4.36 NG/ML. CKMB 1.04/3.65 NG/ML. DIG 1.88/0.542 NG/ML. CKMB 0.257/2.93 NG/ML. TSH 1.85/1.07 UIU/ML. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE EXACT ROOT CAUSE. TROUBLESHOOTING AND MAINTENANCE ACTIVITIES WERE PERFORMED WHICH RESOLVED THE ISSUE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1