BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 CK-MB ASSAY

    MDR report key: 1362631 · Received January 29, 2009

    Report

    Report Number
    2017183-2008-00068
    Event Type
    Other
    Date Received
    January 29, 2009
    Date of Event
    July 4, 2008
    Report Date
    July 5, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS LTD.
    Product Code
    JHX
    PMA / PMN Number
    K034055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A POSITIVE IMMULITE 2500 CK-MB ASSAY RESULT WAS OBTAINED ON A ER PATIENT SAMPLE. A NEWLY DRAWN SAMPLE WAS RUN AND RESULTED POSITIVE. BOTH SAMPLES WAS RESPUN AND RERUN WITH LOWER RESULTS. THE HIGH INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE ER PATIENT WAS TREATED BASED ON THE HIGH INITIAL RESULT AND OTHER ASSAY POSITIVE RESULT. TREATMENT PROVIDED TO THE PATIENT IS UNKNOWN. THERE WAS NO REPORT OF ADVERSE HEALTH IMPACT DUE TO THE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 CK-MB ASSAY CKMB IMMUNOASSAY JHX SIEMENS HEALTHCARE DIAGNOSTICS LTD. NA 126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other