BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3093847 · Received May 6, 2013

    Report

    Report Number
    2247117-2013-00045
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (07/15/2013): A SIEMENS FIELD SERVICE ENGINEER (FSE) HAD BEEN DISPATCHED TO THE CUSTOMER SITE AFTER DISCORDANT PSA RESULTS WERE OBTAINED ON PATIENT SAMPLES. THERE WERE TWO PREVIOUS OCCURRENCES OF DISCORDANT PSA RESULTS ON THE SYSTEM (MDRS 2247117-2013-00013, 2247117-2013-00013_S1, AND 2247117-2013-00039 WERE FILED FOR THE EVENTS), AND AFTER THIS EVENT THE FSE HAD REPLACED THE TIP JAM LEVEL SENSE PRINTED CIRCUIT BOARD, THE MANIFOLD VALVE ASSEMBLY, AND THE BRUSH DOUBLE GROUNDING. DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER CONFIRMED THAT NO DISCORDANT RESULTS HAD BEEN OBTAINED ON THE INSTRUMENT FOLLOWING THE FSE VISIT. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED THE INSTRUMENT DATA FILES FOR THE DATES THE DISCORDANT AND RERUN RESULTS WERE OBTAINED. AFTER EVALUATION OF THE INSTRUMENT DATA, THE GPS SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS THEN DISPATCHED TO THE CUSTOMER SITE. THE FSE PROACTIVELY REPLACED THE TIP JAM LEVEL SENSE PRINTED CIRCUIT BOARD AND THE MANIFOLD VALVE ASSEMBLY. THE CAUSE OF THE DISCORDANT, FALSELY LOW PSA 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 PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN DUPLICATE ON THE SAME INSTRUMENT TWO DAYS LATER, AND RESULTED HIGHER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196340 IMMULITE 2000 XPI IMMULITE 2000 XPI LTJ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1