BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CKMB ASSAY

    MDR report key: 3012370 · Received March 20, 2013

    Report

    Report Number
    1219913-2013-00064
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JHX
    PMA / PMN Number
    K911121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR XP CKMB RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE STATES THE FOLLOWING IN THE INTERPRETATION OF RESULTS SECTION: "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 CKMB 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."

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR CKMB RESULT WAS OBTAINED BY THE CUSTOMER AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT AS THE PATIENT DID NOT HAVE ANY CARDIAC SYMPTOMS. REPEAT TESTING WAS PERFORMED ON A DIFFERENT SAMPLE TUBE AND THE RESULT WAS LOWER. THE CUSTOMER PULLED THE SAMPLE IN QUESTION FROM THE REFRIGERATOR AND FOUND THAT THE SERUM WAS CLOTTED. THE CUSTOMER REPEATED THE SAMPLES BEFORE AND AFTER THIS SAMPLE AND BOTH RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CKMB RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115385 ADVIA CENTAUR XP CKMB ASSAY CKMB IMMUNOASSAY JHX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 185

    Patients

    Seq Age Sex Outcome Treatment
    1