BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 1000 TURBO TROPONIN 1

    MDR report key: 3791831 · Received May 6, 2014

    Report

    Report Number
    2432235-2014-00314
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    November 4, 2013
    Report Date
    April 11, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K991795
    Removal / Correction Number
    2432235-10/27/14-004R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST HAS EVALUATED THE PATIENT DATA. THE CAUSE OF THE FALSELY HIGH TROPONIN RESULTS ON THE IMMULITE 1000 INSTRUMENT IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00314 WAS FILED ON MAY 6, 2104. ADDITIONAL INFORMATION (10/24/14): SIEMENS HAS CONFIRMED THAT THE IMMULITE/IMMULITE 1000 TURBO TROPONIN 1 REAGENT KIT LOTS 319, 321, 322, 323 DEMONSTRATE AN INCREASED FREQUENCY OF 2-7% IN THE NUMBER OF FALSELY ELEVATED TROPONIN VALUES IN PATIENT SAMPLES ABOVE THE 99TH PERCENTILE CLAIM OF >0.30 NG/ML (¿G/L), AS PUBLISHED IN THE INSTRUCTIONS FOR USE (IFU). QUALITY CONTROL IS UNLIKELY TO DETECT THIS ISSUE. THIS ISSUE ONLY IMPACTS THE IMMULITE/IMMULITE 1000 TURBO TROPONIN I ASSAY. SIEMENS IS INVESTIGATING THE ROOT CAUSE OF THE FALSELY ELEVATED TROPONIN VALUES. AN URGENT FIELD SAFETY NOTICE (UFSN) 1112 WAS SENT TO (B)(6) CUSTOMERS IN OCTOBER OF 2014. THE UFSN RECOMMENDS THAT CUSTOMERS TRANSITION TO AN ALTERNATE TROPONIN ASSAY. CUSTOMERS ARE ALSO REQUESTED TO DISCONTINUE AND DISCARD ANY KIT LOTS LISTED ABOVE, REVIEW THE UFSN WITH THEIR MEDICAL DIRECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBTAINED FALSELY HIGH TROPONIN VALUES ON ONE PATIENT SAMPLE FOR THE TURBO TROPONIN ASSAY ON AN IMMULITE 1000 INSTRUMENT, WHEN USING REAGENT LOT 316. THE PATIENT SAMPLE WAS RUN TWICE ON THE IMMULITE 1000 INSTRUMENT AND THE RESULTS WERE HIGH AND DID NOT FIT THE CLINICAL HISTORY OF THE PATIENT. THE SAMPLE WAS THEN RUN ON AN ALTERNATE PLATFORM WHERE THE RESULT WAS NEGATIVE. THE INTIAL RESULTS ON THE IMMULITE 1000 WERE NOT REPORTED TO THE PHYSICIAN(S). THE RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS REPORTED TO PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY HIGH RESULTS OBTAINED ON THE IMMULITE 1000 INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272771 IMMULITE 1000 TURBO TROPONIN 1 IMMULITE 1000 TURBO TROPONIN 1 MMI SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 1000 TURBO TROPONIN 1 316

    Patients

    Seq Age Sex Outcome Treatment
    1