BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGULATION FACTOR VIII DEFICIENT PLASMA

    MDR report key: 20237310 · Received September 17, 2024

    Report

    Report Number
    9610806-2024-00035
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 18, 2024
    Report Date
    October 24, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJT
    UDI-DI
    00842768010996
    PMA / PMN Number
    K924396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THE OBSERVATION OF A FALSELY ELEVATED COAGULATION FACTOR VIII DEFICIENT PLASMA RESULT ON A SYSMEX CN-6000 SYSTEM. PER THE LIMITATIONS SECTION OF THE COAGULATION FACTOR VIII DEFICIENT PLASMA INSTRUCTIONS FOR USE (IFU): "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2024-00035 WAS FILED ON 17-SEP-2024. ADDITIONAL INFORMATION ON 21-OCT-2024: THE INVESTIGATION CONCLUDED THAT THE ISSUE WAS RESOLVED BY PERFORMING ROUTINE TROUBLESHOOTING. QUALITY CONTROL (QC) RESULTS HAVE BEEN FOUND WITHIN RANGE ON THE DAY OF THE EVENT. THE OFFICIAL ASSAY PROTOCOL HAS BEEN USED FOR COAGULATION FACTOR VIII DEFICIENT PLASMA TESTING. SIEMENS CHECKED CALIBRATION CURVES AND DID NOT NOTE ANY ISSUES. SIEMENS INVESTIGATED THE CORRESPONDING SAMPLE KINETIC DATA AND DID NOT IDENTIFIED ANY ISSUES. THE DISCORDANT RESULT WAS FLAGGED WITH "DEFECTIVE SAMPLE VOLUME", THIS FLAG INDICATES THAT THE SAMPLE MIGHT BE UNDERFILLED OR THAT THE SAMPLE WAS ALREADY PROCESSED ON ANOTHER SYSTEM FOR OTHER PARAMETER TESTING. REAGENT ISSUES WERE RULED OUT BASED ON REVIEW OF QC WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. ASSESSMENT OF INSTRUMENT PERFORMANCE INCLUDED A REVIEW OF BACKUP DATA FILES, AND NO ISSUES WERE NOTED. THE CUSTOMER REPORTED DISCORDANT RESULTS VERSUS AN ALTERNATE METHOD, BUT SIEMENS DOES NOT HAVE ANY CLAIM OF EQUIVALENCE TO THE ALTERNATE METHOD AND CANNOT CONCLUDE WHY THE RESULTS FOR THIS INDIVIDUAL PATIENT WERE DIFFERENT ON THE ALTERNATE METHOD. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS INCONCLUSIVE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING. THE COAGULATION FACTOR VIII DEFICIENT PLASMA LOT 560863A IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED COAGULATION FACTOR VIII DEFICIENT PLASMA RESULT ON A SYSMEX CN-6000 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO, BASED ON THE PATIENT'S SEVERE HEMOPHILIA CLASSIFICATION, QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE METHOD. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT AND ALIGNED WITH THE CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED COAGULATION FACTOR VIII DEFICIENT PLASMA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740390 COAGULATION FACTOR VIII DEFICIENT PLASMA PLASMA, COAGULATION FACTOR DEFICIENT GJT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N/A 560863A 00842768010996

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male