BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 2973142 · Received February 21, 2013

    Report

    Report Number
    2247117-2013-00017
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED THE INSTRUMENT DATA. AFTER EVALUATING THE INSTRUMENT DATA, THE GPS SPECIALIST DID NOT FIND ANY INSTRUMENT MALFUNCTION. THE GPS SPECIALIST DID DISCOVER THAT THERE HAD BEEN LEVEL-SENSING ERRORS. AS PER THE IMMULITE 2000 XPI OPERATOR'S MANUAL, LEVEL SENSING ERRORS USUALLY INDICATE AN INSUFFICIENT (I.E., SHORT) SAMPLE AMOUNT. THERE WERE ALSO CLOT DETECTION ERRORS, MEANING THAT A CLOT WAS DETECTED IN THE SAMPLE TUBE. THE CAUSE OF THE DISCORDANT, FALSELY LOW CORTISOL RESULT IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CORTISOL RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S) BECAUSE IT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS RERUN TWICE UNDILUTED AND ONCE DILUTED, AND THE DILUTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CORTISOL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77135 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1