BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 2874288 · Received December 14, 2012

    Report

    Report Number
    2247117-2012-00109
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    August 2, 2012
    Report Date
    February 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    P010053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013: SIEMENS FILED THE INITIAL REPORT ON (B)(4) 2012 ADDITIONAL INFORMATION: INITIAL DISCORDANT RESULTS TESTED ON (B)(6) 2012: PATIENT 1: IMMULITE 2000 RESULT = 97.9 U/ML (COBAS RESULT = 13.6 U/ML), PATIENT 2: IMMULITE 2000 RESULT = 146 U/ML (COBAS RESULT = 29.3 6 U/ML). TESTING OF THE 2 PATIENTS SAMPLES WHICH WERE RETURNED FOR IMMULITE 2000 GIMA (CA 19-9) TESTING. BELOW ARE THE CA 19-9 RESULTS OBTAINED: NEAT HBT PATIENT 1 REP 1 REP 2 MEAN REP1 REP 2 MEAN TUBE DATED (B)(6) 2012 94.2 88.6 91.4 108.0 105.0 106.5 (B)(6) 2012 108.0 95.9 102.0 112.0 118.0 115.0 (B)(6) 2012 14.5 14.0 14.3 15.1 15.1 15.1 PATIENT 2 TUBE DATED (B)(6) 2011 116.0 160.0 138.0 134.0 128.0 131.0 (B)(6) 2012 112.0 113.0 112.5 98.8 94.2 96.5 THE DATES PROVIDED ON THESE SAMPLES DID NOT CORRESPOND TO THE DATE OF THE INITIAL DISCORDANT RESULTS. SAMPLES ARE BEYOND THE DATE TO TEST AND NO DEFINITIVE CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) ANALYZED THE IMMULITE 2000 XPI INSTRUMENT. ANALYSIS OF THE INSTRUMENT INDICATES THAT THE CAUSE FOR THE DISCORDANT CA 19.9 RESULTS IS UNKNOWN, HOWEVER THE FSE CHANGED THE INTERNAL TUBING, DILUTION WELL ASSEMBLY, WATER FILTER,SAMPLE ROTOR GROUND AND FOUND A SAMPLE VALVE LEAKING, WHICH WAS ALSO CHANGED THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    TWO DISCORDANT HIGH IMMULITE 2000 XPI CA 19.9 RESULTS WERE GENERATED ON TWO PATIENT SAMPLES. THE RESULTS WERE COMMUNICATED TO THE PHYSICIANS, WHO QUESTIONED THE RESULTS. THE LABORATORY THEN RERAN THE SAMPLES ON AN ALTERNATE ANALYZER WITH LOWER RESULTS. THERE WAS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT CA 19.9 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 XPI IMMUNO-ASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1