BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGULATION FACTOR VIII DEFICIENT PLASMA

    MDR report key: 20211210 · Received September 13, 2024

    Report

    Report Number
    9610806-2024-00034
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 13, 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 TO REPORT A FALSELY ELEVATED FACTOR VIII RESULT ON A SYSMEX CN-6000 INSTRUMENT. SIEMENS EVALUATED THE ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CAUSED BY A HANDLING ERROR (ERRONEOUS RULE CONFIGURED IN THE SITE'S MIDDLEWARE). THE CUSTOMER IS OPERATIONAL AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING. SYSMEX FACTOR VIII LOT 560836A 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 FACTOR VIII 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. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FACTOR VIII RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263094 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 21 YR Male