BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3082807 · Received April 29, 2013

    Report

    Report Number
    2247117-2013-00040
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 227117-2013-00040 WAS FILED ON APRIL 29, 2013.ADDITIONAL INFORMATION (08/05/2013): SIEMENS GLOBAL PRODUCT SUPPORT (GPS) CONTACTED THE CUSTOMER. THE CUSTOMER STATED THAT THERE WAS NO ADDITIONAL INFORMATION AND NO FURTHER ASSISTANCE WAS REQUIRED.THE CAUSE OF THE DISCORDANT RESULT IS UNKNOWN.NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    POSITIVE ALLERGEN ENQ-WEED RESULTS WERE OBTAINED FOR ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. SPECIFIC ALLERGENS GAVE NEGATIVE RESULTS FOR THE SAME PATIENT. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DILUTION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183438 IMMULITE 2000 IMMULITE 2000 JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1