BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACTOR VIII CHROMOGENIC ASSAY

    MDR report key: 14604885 · Received June 6, 2022

    Report

    Report Number
    9610806-2022-00041
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 6, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGP
    UDI-DI
    00842768004032
    PMA / PMN Number
    K884544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). ALL REACTION KINETICS WERE EVALUATED CORRECTLY BY THE SYSTEM SOFTWARE. THE ISSUE WAS LIMITED TO RESULTS FOR ONE PATIENT. A SAMPLE SPECIFIC ISSUE RELATED TO THE PATIENT'S TREATMENT CANNOT BE RULED OUT AS A POTENTIAL CAUSE OF THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    A DISCORDANT, FALSELY ELEVATED FACTOR VIII RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING FACTOR VIII CHROMOGENIC ASSAY. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A SECOND SAMPLE FROM THE SAME PATIENT THAT WAS DRAWN AT THE SAME TIME WAS MEASURED FOR FACTOR VIII USING A NON-SIEMENS ASSAY, RECOVERING LOWER. IT IS UNKNOWN IF THIS LOWER RESULT WAS CONSIDERED TO BE CORRECT OR IF IT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO DISCORDANT FACTOR VIII RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889526 FACTOR VIII CHROMOGENIC ASSAY FACTOR VIII CHROMOGENIC ASSAY GGP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH FACTOR VIII CHROMOGENIC ASSAY 00199 00842768004032

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Unknown