BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CKMB ASSAY

    MDR report key: 2490256 · Received March 13, 2012

    Report

    Report Number
    1219913-2012-00101
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 17, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLB
    PMA / PMN Number
    K911121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT HIGH CKMB RESULTS IS UNKNOWN. THE INSTRUCTION FOR USE (IFU) INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "SERIAL SAMPLING AT THE APPROPRIATE TIME INTERVALS WILL RESULT IN THE TYPICAL RISE AND FALL PATTERN OF CK-MB LEVELS IN PATIENTS EXPERIENCING MYOCARDIAL INFARCTION. ELEVATED CK-MB LEVELS MAY BE RELATED TO NON-AMI EVENTS SUCH AS CONGESTIVE HEART FAILURE, STRENUOUS EXERCISE, OR TRAUMA. THESE EVENTS SHOULD BE CONSIDERED WHEN INTERPRETING CK-MB RESULTS." NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    FALSELY HIGH ADVIA CENTAUR CKMB RESULTS WERE OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT WHEN COMPARED TO OTHER CKMB TEST METHOD RESULTS. THERE WAS NO REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH ADVIA CENTAUR CKMB ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CKMB ASSAY CKMB IMMUNOASSAY JLB SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1