BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1790593 · Received August 3, 2010

    Report

    Report Number
    2247117-2010-00021
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. THE FSE PROACTIVELY REPLACED THE SAMPLE PROBE. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT CK-MB RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH IMMULITE 2500 CK-MB RESULTS WERE OBTAINED ON ONE PT SAMPLE. THE SAMPLE WAS INITIALLY RUN IN DUPLICATE ON IMMULITE 2500 SN (B)(4). THE SAMPLE WAS RE-TESTED ON THE CUSTOMER'S OTHER IMMULITE 2500 SYSTEM (SN (B)(4)) BECAUSE THE INITIAL RESULTS DID NOT AGREE WITH THE PT'S CLINICAL HISTORY. (CK-MB RESULTS OBTAINED FOR THIS PT 5 HOURS EARLIER WERE NOT HIGH.) PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CK-MB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1