BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP MYOGLOBIN ASSAY

    MDR report key: 3062685 · Received April 17, 2013

    Report

    Report Number
    1219913-2013-00078
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DDR
    PMA / PMN Number
    K974325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP MYOGLOBIN RESULT IS UNKNOWN. THE INVESTIGATION IS ONGOING. NO CONCLUSION CAN BE DRAWN. THE IFU STATES IN THE SUMMARY AND EXPLANATION OF THE TEST: "MYOGLOBIN HAS A NEGATIVE PREDICTIVE VALUE OF 99%, WHICH IMPROVES THE RULE OUT CAPABILITIES OF THE EMERGENCY DEPARTMENT AND HELPS REDUCE THE NUMBER OF PATIENTS INAPPROPRIATELY ADMITTED TO THE CORONARY CARE UNITS WITH SYMPTOMS ATYPICAL OF ACUTE MYOCARDIAL INFARCTION. WHEN USED IN COMBINATION WITH OTHER CARDIAC MARKERS SUCH AS CK-MB OR TROPONIN I, MYOGLOBIN IS A VALUABLE DIAGNOSTIC TOOL TO BE USED IN THE EARLY EVALUATION OF THE POTENTIAL ACUTE MYOCARDIAL INFARCTION PATIENT."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON APRIL 17, 2013. 09/23/2013 ADDITIONAL INFORMATION: A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE VERIFIED THAT THE ASPIRATION PROBES HAVE GOOD FUNCTIONALITY. THE FSE CHECKED THE SAMPLE PROBE TO CUVETTE CALIBRATION AND ADJUSTED PROPERLY. THE DISCORDANT PATIENT SAMPLE WAS RUN AND THE RESULTS WERE GOOD. THE QUALITY CONTROL WAS RUN AND THE RESULTS WERE ACCEPTABLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY LOW ADVIA CENTAUR XP MYOGLOBIN TEST RESULTS WERE OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT TEST RESULTS ON ALTERNATE ADVIA CENTAUR XP SYSTEM. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP MYOGLOBIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164215 ADVIA CENTAUR XP MYOGLOBIN ASSAY MYOGLOBIN IMMUNOASSAY DDR SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 176

    Patients

    Seq Age Sex Outcome Treatment
    1