BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1478401 · Received September 15, 2009

    Report

    Report Number
    2247117-2009-00034
    Event Type
    Other
    Date Received
    September 15, 2009
    Date of Event
    August 13, 2009
    Report Date
    August 14, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    CKG
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE TECHNICAL SUPPORT ENGINEER (TSE) ANALYZED THE INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT RESULT WAS DUE TO THE REAGENT LEVEL SENSE ERROR. THE CAUSE OF THE REAGENT LEVEL SENSE ERROR IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ACTH RESULT WAS OBTAINED ON A PT SAMPLE, GENERATED ON AN IMMULITE 2000. THE SAMPLE WAS REPEATED AND THE RESULT WAS REPORTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ACTH RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1