BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGULATION FACTOR VIII DEFICIENT PLASMA

    MDR report key: 7165793 · Received January 4, 2018

    Report

    Report Number
    9610806-2018-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 9, 2017
    Report Date
    January 4, 2018
    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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS DETERMINED THAT THE CAUSE OF THE DISCORDANT COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS GENERATED ON THE BCS XP ANALYZER SN (B)(4) WAS DUE TO A REAGENT SYRINGE THAT REQUIRED REPLACEMENT ON THE SYSTEM. ONCE THE REAGENT SYRINGE WAS REPLACED, THE COAGULATION FACTOR VIII DEFICIENT PLASMA TEST WAS RERUN ON THE BCS XP ANALYZER SN (B)(4) AND THE RESULTS GENERATED WERE ACCEPTABLE. THE INSTRUMENT AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS FOR ONE PATIENT WERE GENERATED ON THE BCS XP ANALYZER (SN (B)(4)). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. ALL QUALITY CONTROL (QC) WAS IN RANGE ON THIS BCS XP ANALYZER. THE SAME PATIENT SAMPLE WAS REPEATED ON THE SAME BCS XP ANALYZER AND DISCORDANT COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS WERE GENERATED ONCE AGAIN. NO DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS THEN RUN ON A CA-7000 ANALYZER AND ON A DIFFERENT BCS XP ANALYZER (SN (B)(4)). THE COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS GENERATED ON THE CA-7000 ANALYZER WERE NOT CONSIDERED DISCORDANT (MEAN OF 34.2%) AND CONSISTENT WITH THE PATIENT RESULTS GENERATED ON THE BCS XP ANALYZER SN (B)(4) (MEAN OF 33.2%). THE COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULT GENERATED ON THE BCS XP ANALYZER SN (B)(4) (MEAN OF 33.2%) WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7267 COAGULATION FACTOR VIII DEFICIENT PLASMA COAGULATION FACTOR VIII DEFICIENT PLASMA GJT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 547642A 00842768010996

    Patients

    Seq Age Sex Outcome Treatment
    1