BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1940962 · Received December 17, 2010

    Report

    Report Number
    2247117-2010-00056
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE IMMULITE 2000 INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THERE WERE NO ISSUES FOUND IN THE FILES AND THE CAUSE FOR THE FALSE NEGATIVE ALLERGEN TEST RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT NONREACTIVE (NEGATIVE) IMMULITE 2000 ALLERGEN TEST RESULTS WERE OBTAINED ON ONE PT SAMPLE. REPEAT TESTING AND A NEW SAMPLE DRAW SHOWED CONSISTENT RESULTS. PT SUFFERED AND WAS TREATED FOR ANAPHYLACTIC SHOCK (PRIOR TO SURGERY) AFTER THE ADMINISTRATION OF ANTIBIOTICS. WHEN TESTED ON A DIFFERENT SYSTEM, THE RESULTS WERE REACTIVE (POSITIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1