BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1297048 · Received January 26, 2009

    Report

    Report Number
    2247117-2009-00003
    Event Type
    Other
    Date Received
    January 26, 2009
    Date of Event
    December 22, 2008
    Report Date
    December 23, 2008
    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. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN (RTI) AND CK-MB (RCK) RESULTS WERE DUE TO THE SAMPLE LEVEL SENSE ERROR. THE CAUSE OF THE SAMPLE LEVEL SENSE ERROR IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT TROPONIN (RTI) AND CK-MB (RCK) RESULTS WERE OBTAINED ON A PT SAMPLE. THE SAMPLE WAS REPEATED IN DUPLICATE AND TWO POSITIVE TROPONIN (RTI) AND CK-MB (RCK) RESULTS WERE OBTAINED. THE POSITIVE TROPONIN (RTI) AND CK-MB (RCK) RESULT WAS REPORTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCE AS A RESULT OF THE DISCORDANT TROPONIN (RTI) RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1