BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 CK-MB ASSAY

    MDR report key: 1282044 · Received December 16, 2008

    Report

    Report Number
    2017183-2008-00059
    Event Type
    Other
    Date Received
    December 16, 2008
    Date of Event
    September 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS LTD.
    Product Code
    JHX
    PMA / PMN Number
    K004002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THE CAUSE FOR THE DISCORDANT CK-MB RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    MULTIPLE POSITIVE IMMULITE 2000 CK-MB PATIENT SAMPLE RESULTS WERE OBTAINED. THE SAMPLES WERE RUN ON OTHER CKMB ASSAYS OTHER THAN THE IMMULITE 2000 WITH NORMAL RESULTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CK-MB RESULT.

    Additional Manufacturer Narrative · 2

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THE CAUSE FOR THE DISCORDANT CK-MB RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    MULTIPLE POSITIVE IMMULITE 2000 CK-MB PATIENT SAMPLE RESULTS WERE OBTAINED. THE SAMPLES WERE RUN ON OTHER CKMB ASSAYS OTHER THAN THE IMMULITE 2000 WITH NORMAL RESULTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CK-MB RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 CK-MB ASSAY CKMB IMMUNOASSAY JHX SIEMENS HEALTHCARE DIAGNOSTICS LTD. NA 206

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR
    2 47 YR