BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCS XP SYSTEM

    MDR report key: 6904321 · Received September 29, 2017

    Report

    Report Number
    9610806-2017-00106
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 29, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GKP
    UDI-DI
    00630414945514
    PMA / PMN Number
    K970431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO DETERMINE THE CAUSE OF THE DISCORDANT PROTHROMBIN TIME (PT) RESULTS. THE CSE REPLACED THE DISINFECTANT PUMP UNIT, INTERFACE P BOARD, HC11D IN THE INTERFACE P BOARD, PELT BOARD, AND X-Y COM CABLE FOR BOTH ARMS AND CSE ADJUSTED THE 5V AND 24V SUPPLY. THE CSE RESTORED GLOBALS AND EEPROM PARAMETERS AND CLEARED ERRORS. THE CSE PERFORMED DIAGNOSTIC CHECKS WITH NO ISSUES AND RAN INTERNAL QUALITY CONTROLS, WHICH RECOVERED WITHIN RANGE. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. THE SYSTEM AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS WERE OBTAINED ON 9 PATIENT SAMPLES ON THE BCS XP SYSTEM. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. ONE PATIENT ((B)(4)) WAS TREATED WITH A DOSE OF VITAMIN K DUE TO THE DISCORDANT RESULT. THE SAME PATIENT SAMPLES WERE RERUN AT ANOTHER FACILITY ON AN ALTERNATE BCS XP SYSTEM, RESULTING LOWER. CORRECTED REPORTS WERE PROVIDED TO THE PHYSICIAN(S). A DISCORDANT, FALSELY LOW PT RESULT WAS OBTAINED ON ANOTHER PATIENT SAMPLE ON THE SAME BCS XP SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAME PATIENT SAMPLE WAS RERUN AT THE OTHER FACILITY ON THE OTHER BCS XP SYSTEM, RESULTING HIGHER. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS ADVERSE HEALTH CONSEQUENCES AS THE CUSTOMER INFORMED THE REGISTERED NURSE (RN) ABOUT THE DISCORDANT RESULTS AND ADVISED THE RN TO NOT ACT ON THE DISCORDANT RESULTS. THE CUSTOMER INDICATED THAT THE HOSPITAL'S INTERNAL AUDIT, PERFORMED BY THE QUALITY ASSURANCE DEPARTMENT, INDICATED THAT NO ADVERSE PATIENT CARE OR HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684705 BCS XP SYSTEM BCS XP SYSTEM GKP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM 00630414945514

    Patients

    Seq Age Sex Outcome Treatment
    1