BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2874356 · Received December 14, 2012

    Report

    Report Number
    2247117-2012-00108
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE COULD NOT FIND ANY INSTRUMENT MALFUNCTION. THE CAUSE OF THE DISCORDANT PSA RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE IMMULITE 2000 INSTRUMENT. IT WAS DISCOVERED THAT TWO PATIENT SAMPLES HAD HIGHER RESULTS UPON RERUN. IT IS UNKNOWN WHETHER THE DISCORDANT, FALSELY LOW PSA RESULTS FOR TWO THOSE PATIENTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT THE LABORATORY WOULD LOOK AT HISTORIES OF PATIENTS WHOSE SAMPLES RESULTED LESS THAN 0.09 NG/ML, AND RERUN SAMPLES THAT WERE NOT CONSISTENT WITH PATIENT HISTORIES. THE CUSTOMER THEN FAXED DATA FOR TWO ADDITIONAL PATIENTS WITH DISCORDANT, FALSELY LOW PSA RESULTS. FOR ONE PATIENT, THE INITIAL, DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE LABORATORY SENT THE SAMPLE TO A REFERENCE LABORATORY (ARUP) FOR THIRD GENERATION PSA TESTING. UPON RECEIVING THE REFERENCE LABORATORY'S RESULT, THEY RERAN THE PATIENT SAMPLE AND ALSO SENT TO A THIRD LABORATORY ((B)(6)) FOR BOTH TOTAL PSA AND FREE PSA TESTING. IT IS UNKNOWN WHETHER THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). FOR THE OTHER PATIENT, THE INITIAL, DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE OPERATOR QUESTIONED THE RESULT DUE TO THE PATIENT'S HISTORY, AND RERAN THE PATIENT SAMPLE IN DUPLICATE. THE CORRECT RESULT WAS THEN REPORTED TO THE PHYSICIAN(S), WITHIN ONE HOUR OF THE INITIAL RESULT BEING REPORTED. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMULITE 2000 LTJ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1