BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY

    MDR report key: 5898152 · Received August 23, 2016

    Report

    Report Number
    1219913-2016-00146
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 23, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE OUT OF RANGE TROPONIN ULTRA QC LEVEL 3 RESULTS IS USE ERROR. THE CUSTOMER DID NOT UPDATE TO THE REVISED QC RANGES ACCORDING TO CUSTOMER BULLETIN 11222652, REV. A. THE REVISED QC RANGES HAVE BEEN UPDATED AND THE QC IS WITHIN RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE UNDER THE QUALITY CONTROL SECTION 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

    THE CUSTOMER OBTAINED OUT OF RANGE RESULTS FOR THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) QUALITY CONTROL (QC) LEVEL 3 WHEN USING REAGENT LOT 112 WITH QC LOT 23603. THE CUSTOMER WAS NOT AWARE OF THE NEW ANTIBODY CUSTOMER BULLETIN. THE CUSTOMER DID NOT CHANGE THE QC RANGES WITH NEW ANTIBODY TROPONIN ULTRA LOT 110. THE CUSTOMER PERFORMED RECALIBRATION AND REPEATED THE QC UNTIL IN RANGE. THE CUSTOMER BULLETIN 11222652, REV. A ISSUED ON MAY 2016 WAS FAXED TO THE CUSTOMER. THE BIO-RAD QUALITY CONTROL REVISED RANGES WERE ALSO PROVIDED. THE CUSTOMER UPDATED TO THE REVISED RANGES FOR THE BIO-RAD QUALITY CONTROL. THE QC HAS BEEN IN RANGE. PATIENT RESULTS WERE NOT AFFECTED. NO PATIENT SAMPLES WERE RUN WHILE QC WAS OUT OF RANGE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE OUT OF RANGE TROPONIN ULTRA QC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547638 ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 112

    Patients

    Seq Age Sex Outcome Treatment
    1