BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACTOR VIII CHROMOGENIC ASSAY

    MDR report key: 7053625 · Received November 22, 2017

    Report

    Report Number
    9610806-2017-00134
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 12, 2017
    Report Date
    November 22, 2017
    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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE PROVIDED INFORMATION TO DETERMINE THE CAUSE OF THE DISCORDANT, HIGH FACTOR VIII PATIENT RESULT ON THE BCS XP SYSTEM. NO PRODUCT NON-CONFORMANCE COULD BE IDENTIFIED AND ALL INFORMATION THAT WAS PROVIDED INDICATES A POSSIBLE SAMPLE SPECIFIC ISSUE. THE INSTRUMENT AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, HIGH FACTOR VIII PATIENT RESULT (CHROMOGENIC FACTOR VIII ASSAY) WAS GENERATED ON THE BCS XP SYSTEM COMPARED TO A CHROMOGENIC FACTOR VIII ASSAY PATIENT RESULT GENERATED AT ANOTHER REFERENCE LAB (ESOTERIX). A DIFFERENT PATIENT SAMPLE (FROM THE SAME PATIENT) WAS USED AT ESOTERIX, BUT IT IS NOT KNOWN WHAT SYSTEM WAS USED. FACTOR VIII ACTIVITY WAS ALSO HIGH ON THAT PATIENT SAMPLE ON THE BCS XP SYSTEM COMPARED TO THE FACTOR VIII ACTIVITY RESULT GENERATED AT THE REFERENCE LAB (ESOTERIX). QUALITY CONTROLS WERE IN RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, HIGH FACTOR VIII PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831438 FACTOR VIII CHROMOGENIC ASSAY FACTOR VIII CHROMOGENIC ASSAY GGP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 529391 00842768004032

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR