BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 2862543 · Received December 10, 2012

    Report

    Report Number
    1219913-2012-00403
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE INITIAL POSITIVE ADVIA CENTAUR CP RESULT WHEN COMPARED TO THE NEGATIVE REPEAT TEST RESULTS IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE ACCEPTABLE AT THE TIME OF THE EVENT. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2012-00403 ON (B)(4) 2012. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND FOUND NO SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT RESULT. THE CUSTOMER HAS STATED THAT THE SAMPLE IS CENTRIFUGED PRIOR TO BEING RECEIVED IN THE LABORATORY FOR TESTING AND WAS UNABLE TO VERIFY SAMPLE HANDLING OR COLLECTION. THE CAUSE FOR THE FALSE POSITIVE RESULT MAY BE ATTRIBUTED TO SPECIMEN COLLECTION AND HANDLING. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING IN THE SPECIMEN COLLECTION AND HANDLING: "THE FOLLOWING RECOMMENDATIONS FOR HANDLING AND STORING BLOOD SAMPLES ARE FURNISHED BY THE CLINICAL AND LABORATORY STANDARDS INSTITUTE (CLSI, FORMERLY NCCLS): COLLECT ALL BLOOD SAMPLES OBSERVING UNIVERSAL PRECAUTIONS FOR VENIPUNCTURE. ALLOW SAMPLES TO CLOT ADEQUATELY BEFORE CENTRIFUGATION. KEEP TUBES STOPPERED AND UPRIGHT AT ALL TIMES. DO NOT USE SAMPLES THAT HAVE BEEN STORED AT ROOM TEMPERATURE FOR LONGER THAN 4 HOURS. TIGHTLY CAP AND REFRIGERATE SPECIMENS AT 2° TO 8°C IF THE ASSAY IS NOT COMPLETED WITHIN 4 HOURS. FREEZE SAMPLES AT OR BELOW -20°C IF THE SAMPLE IS NOT ASSAYED WITHIN 24 HOURS. FREEZE SAMPLES ONLY ONCE AND MIX THOROUGHLY AFTER THAWING. FROZEN SPECIMENS CAN REMAIN FROZEN UP TO 1 MONTH IN NON-FROST FREE FREEZERS. FROZEN SAMPLES MUST BE CENTRIFUGED AT 2200 X G FOR 10 MINUTES BEFORE ANALYSIS." "BEFORE PLACING SAMPLES ON THE SYSTEM, ENSURE THAT SAMPLES HAVE THE FOLLOWING CHARACTERISTICS: FREE OF FIBRIN OR OTHER PARTICULATE MATTER. FREE OF BUBBLES."

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO THE REPEAT TROPONIN TEST RESULTS. THE CUSTOMER'S PROTOCOL IS TO REPEAT ALL INITIALLY POSITIVE TROPONIN TEST RESULTS. THE CUSTOMER REPORTED A NEGATIVE RESULT. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 067

    Patients

    Seq Age Sex Outcome Treatment
    1