BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERICHROM ANTITHROMBIN III

    MDR report key: 6986810 · Received October 30, 2017

    Report

    Report Number
    9610806-2017-00119
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 5, 2017
    Report Date
    October 30, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JPE
    UDI-DI
    00842768013461
    PMA / PMN Number
    K933125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE PROVIDED INFORMATION TO DETERMINE THE CAUSE OF THE DISCORDANT, LOW ATIII PATIENT SAMPLE RESULT ON THE ATELLICA COAGULATION 360 SYSTEM. NO PRODUCT NON-CONFORMANCE COULD BE IDENTIFIED AND A POSSIBLE CAUSE OF THE EVENT MAY BE RELATED TO SAMPLE HANDLING. 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, LOW BERICHROM ANTITHROMBIN III (ATIII) PATIENT SAMPLE RESULT OF <15% WAS GENERATED ON THE ATELLICA COAG 360 SYSTEM AND WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED AGAIN ON THE SAME SYSTEM AND AN ATIII RESULT OF 95.2% WAS GENERATED. THE SAME PATIENT SAMPLE WAS REPEATED ON A BCS XP SYSTEM AND AN ATIII RESULT (NOT PROVIDED BY CUSTOMER) WAS GENERATED THAT WAS CONSISTENT WITH THE 95.2% RESULT ON THE ATELLICA COAG 360 SYSTEM. ALL QUALITY CONTROL RESULTS WERE WITHIN RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, LOW ATIII RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765796 BERICHROM ANTITHROMBIN III BERICHROM ANTITHROMBIN III JPE SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 46999 00842768013461

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR