BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XT-4000I

    MDR report key: 6576812 · Received May 18, 2017

    Report

    Report Number
    1000515253-2017-00018
    Event Type
    Malfunction
    Date Received
    May 18, 2017
    Date of Event
    March 30, 2017
    Report Date
    May 16, 2017
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K091313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS SHIPPED TO THE MANUFACTURER FOR FURTHER INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    WHILE ASSESSING THE ANALYZER, THERE WAS NO EVIDENCE OF LEAKAGE FROM THE VALVE UNITS. HOWEVER, A SHORT-CIRCUIT IN WIRING CORD NO. 3185 WAS DISCOVERED. THE PRINTED CIRCUIT BOARD (PCB) AND WIRING CORD CHARRED AS A RESULT OF EXCESS CURRENT. THIS ISSUE WAS DETERMINED TO BE AN ISOLATED EVENT DUE TO EXCESS CURRENT OF UNKNOWN ORIGIN. THERE WAS NO SYSTEMIC DEFICIENCY IDENTIFIED. NO FURTHER CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE ANALYZER GENERATED AN ERROR MESSAGE STATING "STROMATOLYSER-FB(FBA) REPLACE CONTAINER." THIS ERROR INDICATES INSUFFICIENT REAGENT, A DEFECTIVE SENSOR AND/OR AN ABNORMALITY IN THE HYDRAULIC SYSTEM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND OXIDIZATION ON THE BUBBLE SENSOR CONNECTOR. THE WIRING ATTACHED TO THE PRINTED CIRCUIT BOARD (PCB) WAS MELTED AND CHARRING WAS OBSERVED.

    Description of Event or Problem · 1

    ON MAY 10, 2017 SYSMEX CORPORATION (B)(4) (S-CORP) RECEIVED THE XT-4000I FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357760 XT-4000I XT-4000I AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XT-4000I

    Patients

    Seq Age Sex Outcome Treatment
    1