BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VWF AG

    MDR report key: 24980010 · Received April 24, 2026

    Report

    Report Number
    9610806-2026-00009
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 21, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGP
    UDI-DI
    000842768006661
    PMA / PMN Number
    K220728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT A DISCORDANT RESULT THAT WERE OBTAINED FOR ONE PATIENT SAMPLE ON THE CS-5100 INSTRUMENT FOR THE ASSAY VWF AG. SIEMENS IS INVESTIGATING THE ISSUE. IN ADDITION THE CUSTOMER REPORTED DISCORDANT RESULTS THAT WERE OBTAINED ON THE SAME PATIENT SAMPLE AND ON ONE ADDITIONAL PATIENT SAMPLES ON THE CS-5100 INSTRUMENT FOR THE ASSAY INNOVANCE VWF AC. A SEPARATE REPORT WAS FILED FOR INNOVANCE VWF AC RESULTS. VWF AG REAGENT IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER 10483455. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DEPRESSED VWF-AG (VON-WILLEBRAND FACTOR ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A CS-5100 INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, DEPRESSED VWF-AG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381437 VWF AG TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY GGP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 03503 000842768006661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown