BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGULATION FACTOR IX DEFICIENT PLASMA

    MDR report key: 3504200 · Received December 6, 2013

    Report

    Report Number
    9610806-2013-00033
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    August 6, 2013
    Report Date
    November 7, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJT
    PMA / PMN Number
    K924396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY ELEVATED FIX RESULTS IS USER ERROR. THE CUSTOMER WENT LIVE WITH THE FIX ASSAY IN (B)(6) 2013. THE ASSAY IS A USER DEFINED METHOD WHICH REQUIRES VALIDATION/VERIFICATION BY THE CUSTOMER. HOWEVER, AT THE TIME OF INSTALLATION OF THE METHOD, INSUFFICIENT CONTROL MATERIAL WAS AVAILABLE TO PERFORM VALIDATION/VERIFICATION. THE SIEMENS TECHNICAL ASSISTANCE SPECIALIST ASSISTED IN THE SET-UP OF THE USER DEFINED METHOD BY DUPLICATING THE DEFINED METHOD SETTINGS FOR THE FACTOR VIII TEST BUT DUE TO LACK OF PATIENT SAMPLES AT THAT TIME, THE FIX ASSAY COULD NOT BE VERIFIED. THE BCS(R) XP SYSTEM INSTRUCTION MANUAL IN THE LABORATORY-SPECIFIC DEFINITIONS AND SETTINGS SECTION STATES: IT IS THE RESPONSIBILITY OF THE USER TO VALIDATE ANY MODIFICATIONS MADE TO THESE INSTRUCTIONS, INSTRUMENTS, REAGENTS OR SOFTWARE PROVIDED BY DADE BEHRING." THE ROOT CAUSE WAS DETERMINED TO BE FACTOR IX 1:20 AND 1:40 ASSAY DEFINITIONS WERE LINKED INCORRECTLY TO FACTOR IX 1:10 ASSAY PROCEDURE. WHEN THE FACTOR IX 1:20 AND 1:40 ASSAY WAS ORDERED, THE ANALYZER RAN THE 1:10 DILUTION. THE RESULT FACTOR WAS SET CORRECTLY. CONSEQUENTLY, THE INCORRECT RAW VALUES WITH THE RESULT FACTOR APPLIED CAUSE THE FACTOR IX RESULTS FOR THE THREE DILUTIONS TO APPEAR TO INDICATE THE PRESENCE OF AN INHIBITOR. THE RESULTS APPEAR WITH THE 1:20 AND 1:40 RESULTS MULTIPLIED BY THE INCORRECT DILUTION FACTOR AND THE RESULTS TO BE PRINTED WITH THE "POSSIBLE INHIBITOR" COMMENT. THE ACCOUNT CONTACTED THE PHYSICIAN UPON BECOMING AWARE OF THE ERROR IN SETTING AND HAS CONFIRMED, "THERE WAS NO ILL EFFECT ON THE TREATMENT OF THESE PATIENTS BASED ON THE FACTOR IX RESULTS WE ORIGINALLY REPORTED." THE ACCOUNT HAS CORRECTED THE ASSAY SETTING AND VALIDATED THE CORRECTED SETTINGS.

    Description of Event or Problem · 1

    FALSELY ELEVATED COAGULATION FACTOR IX (FIX) RESULTS WERE REPORTED ON SERIES OF A SINGLE PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN WITH NO INDICATION THAT RESULTS WERE QUESTIONED. AT A LATER DATE WHEN THE ACCOUNT BECAME AWARE OF FAILURES ON CAP SURVEY SAMPLES, IT WAS DETERMINED THAT THE RESULTS WERE FALSELY ELEVATED. IT IS UNKNOWN IF THE PATIENT WAS TREATED ON THE BASIS OF THE REPORTED FALSELY ELEVATED FIX RESULTS. HOWEVER, SINCE THE PATIENT WAS TREATED BY THE ADMINSTRATION OF FACTOR IX, IT IS LIKELY THAT THE PHYSICIAN QUESTIONED THE REPORTED 1:40 RESULT DUE TO THE ACCOMPANYING "POSSIBLE INHIBITOR" FLAG. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE INITIAL FALSELY ELEVATED FIX RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634228 COAGULATION FACTOR IX DEFICIENT PLASMA COAGULATION FACTOR IX DEFICIENT PLASMA GJT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 500865

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR