BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3111508 · Received May 14, 2013

    Report

    Report Number
    2247117-2013-00048
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 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

    THE CAUSE OF THE DISCORDANT RESULT BETWEEN THE FOOD PANEL AND THE INDIVIDUAL ALLERGENS IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (08/06/2013): SIEMENS TECHNICAL OPERATIONS PERFORMED AN INVESTIGATION ON THE PR10 PROTEIN IN THE ALLERGEN PANEL. THE DATA DEMONSTRATED THAT THE PR10 PROTEIN IS RUNNING AS EXPECTED. TECHNICAL OPERATIONS DID IDENTIFY ONE SAMPLE THAT WAS LOWER ON THE IMMULITE WHEN COMPARED TO AN ALTERNATE PLATFORM, AND ONE SAMPLE THAT WAS DETECTED ON THE IMMULITE BUT MISSED ON THE ALTERNATE PLATFORM. A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST CONTACTED THE CUSTOMER AND INFORMED THEM THAT ADDITIONAL TESTING WILL BE PERFORMED INTERNALLY FOR MONITORING AND IMPROVEMENT. THE CUSTOMER IS SATISFIED WITH THE RESPONSE AND INFORMED GPS THAT NO FURTHER ASSISTANCE WAS REQUIRED. THE CAUSE OF THE DISCORDANT RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A NEGATIVE ALLERGEN FOOD PANEL RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE SPECIFIC ALLERGEN TESTING GAVE A POSITIVE RESULT FOR THE SAME PATIENT. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE FOOD ALLERGEN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212990 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1