BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY

    MDR report key: 3893456 · Received June 25, 2014

    Report

    Report Number
    1219913-2014-00146
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Removal / Correction Number
    1219913-05/30/2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY CALIBRATED THE ADVIA CENTAUR XP TNI ULTRA ASSAY TWO TIMES AND THE QC MATERIAL RESULTS WERE HIGH OUT OF THE CUSTOMER'S DEFINED RANGES BUT WITHIN THE MANUFACTURER'S DEFINED RANGES. THEY CALIBRATED A THIRD TIME AND THE QC RESULTS WERE WITHIN THE CUSTOMER'S DEFINED RANGES BUT AT THE HIGH END OF THE RANGES. ALL THREE CALIBRATIONS WERE PERFORMED ON THE SAME READYPACK. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT ON SITE AND PERFORMED A TOTAL SERVICE PROTOCOL AND COMPLETE VISION PROTOCOLS. NO ISSUES WERE OBSERVED. CSE NOTICED THAT THE READYPACK ONBOARD THE SYSTEM WAS DARKER IN COLOR THAN OTHER READYPACKS. NO CONCLUSIONS CAN BE DRAWN. CUSTOMER WAS ADVISED TO FOLLOW URGENT MEDICAL DEVICE CORRECTION 108183632 REGARDING THE CALIBRATION OF EVERY READYPACK OF ADVIA CENTAUR TROPONIN ULTRA UNTIL REAGENT LOT 010086 WAS RECEIVED. THE SYSTEM IS PERFORMING TO SPECIFICATION. THE QUALITY CONTROL SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "SIEMENS HEALTHCARE DIAGNOSTICS RECOMMENDS THE USE OF COMMERCIALLY AVAILABLE QUALITY CONTROL MATERIALS WITH AT LEAST 2 LEVELS (LOW AND HIGH.) A SATISFACTORY LEVEL OF PERFORMANCE IS ACHIEVED WHEN THE ANALYTE VALUES OBTAINED ARE WITHIN THE ACCEPTABLE CONTROL RANGE FOR THE SYSTEM OR WITHIN YOUR RANGE, AS DETERMINED BY AN APPROPRIATE INTERNAL LABORATORY QUALITY CONTROL SCHEME. IF THE QUALITY CONTROL RESULTS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S ESTABLISHED VALUES, DO NOT REPORT RESULTS. TAKE THE FOLLOWING ACTIONS: VERIFY THAT THE MATERIALS ARE NOT EXPIRED. VERIFY THAT REQUIRED MAINTENANCE WAS PERFORMED. VERIFY THAT THE ASSAY WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE. RERUN THE ASSAY WITH FRESH QUALITY CONTROL SAMPLES. IF NECESSARY, CONTACT YOUR LOCAL TECHNICAL SUPPORT PROVIDER OR DISTRIBUTOR FOR ASSISTANCE."

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR QUALITY CONTROL (QC) RESULTS WERE OUT OF RANGE HIGH FOR ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA). THE CUSTOMER CALIBRATED THREE TIMES AND THE QC RESULTS CAME IN RANGE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH, OUT OF RANGE QC RESULTS ON ADVIA CENTAUR XP TNI ULTRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371916 ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010084

    Patients

    Seq Age Sex Outcome Treatment
    1