BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 5209822 · Received November 9, 2015

    Report

    Report Number
    1219913-2015-00166
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 22, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2015-00166 ON NOVEMBER 9, 2015. SIEMENS FILED THE MDR 1219913-2015-000166 SUPPLEMENTAL REPORT 1 ON NOVEMBER 12, 2015. 12/09/2015 ADDITIONAL INFORMATION: SIEMENS PERSONNEL VISITED THE CUSTOMER SITE. DEBRIS WAS OBSERVED IN THE SAMPLE AND CUVETTE WASTE INDICATING SAMPLE INTEGRITY ISSUE. THE SIEMENS FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE WASH STATION, LUMINOMETER AND PERISTALTIC PUMP. FORTY REPLICATES OF THE LOW CALIBARATOR, LOW QUALITY CONTROL, AND NEGATIVE PATIENT POOL WERE RUN POST SERVICE. ALL THE RESULTS WERE ACCEPTABLE. THE CUSTOMER SITE HAS NOT HAD ANY OTHER DISCORDANT RESULTS SINCE SERVICE. THE CUSTOMER DOES NOT ADHERE TO THE SAMPLE TUBE MANUFACTURER'S RECOMMENDED HANDLING. PREANALYTICAL FACTORS CANNOT BE RULED OUT LEADING TO FIBRIN INTERFERENCE AS THE CAUSATIVE AGENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE SPECIMEN COLLECTION AND HANDLING SECTION: "BEFORE PLACING SAMPLES ON THE SYSTEM, ENSURE THAT SAMPLES HAVE THE FOLLOWING CHARACTERISTICS: FREE OF FIBRIN OR OTHER PARTICULATE MATTER. FREE OF BUBBLES."

    Additional Manufacturer Narrative · 1

    THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) HAS BEEN AT THE CUSTOMER SITE SEVERAL TIMES. IN THE MOST RECENT VISIT, THE CSE DECONTAMINATED THE SYSTEM AND REPLACED THE SYSTEM WATER BOTTLE AND WASH 1 BOTTLE WITH BRAND NEW BOTTLES. THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES THE FOLLOWING: "ALWAYS ANALYZE CTNI RESULTS IN THE CONTEXT OF TIME ELAPSED SINCE PATIENT PRESENTATION TO THE HOSPITAL. SERIAL SAMPLING IS RECOMMENDED TO DETECT THE TEMPORAL RISE AND FALL OF TROPONIN LEVELS CHARACTERISTIC OF MI. IN ACCORD WITH PUBLISHED RECOMMENDATIONS, SERIAL TESTING OF CTNI AT INTERVALS OF 2 TO 4 HOURS FOR UP TO 12 TO 24 HOURS IS SUGGESTED TO CORROBORATE A SINGLE CTNI RESULT. AN ELEVATED TROPONIN ALONE IS NOT SUFFICIENT TO MAKE THE DIAGNOSIS OF MI. OTHER MARKERS, SUCH AS CK-MB AND MYOGLOBIN, CAN BE USED IN CONJUNCTION WITH CTNI RESULTS IN AIDING THE DIAGNOSIS OF MI."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2015-00166 ON NOVEMBER 9, 2015. 11/06/2015 ADDITIONAL INFORMATION: THE CUSTOMER OBTAINED TROPONIN ULTRA DISCORDANT RESULTS FOR SAMPLES FROM TWO PATIENTS. THE INITIAL RESULTS FOR THE SAMPLES WERE ELEVATED AND REPEATED NEGATIVE. (B)(6) 2015 PATIENT SAMPLE WITH LOT 097: INITIAL: 0.34 NG/ML, REPEAT: 0.01 NG/ML. LOT 097: EXPIRATION DATE 04/22/2016 MANUFACTURE DATE 06/22/2015. (B)(6) 2015 PATIENT SAMPLE WITH LOT 099: INITIAL: 0.17 NG/ML, REPEAT: 0.04 NG/ML. LOT 099: EXPIRATION DATE 06/03/2016, MANUFACTURE DATE 08/03/2015. THE SAMPLES WERE SPUN IN A STAT SPIN AT 7500 RPMS FOR 3 MINS. SAMPLE TYPE IS PLASMA, LITHIUM HEPARIN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE NEGATIVE. THE PATIENT SAMPLE WAS RUN ON THE ADVIA CENTAUR IN THE UPSTAIRS LABORATORY AND THE RESULT WAS NEGATIVE. THE NEGATIVE RESULT WAS REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741131 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 097

    Patients

    Seq Age Sex Outcome Treatment
    1