BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 20181904 · Received September 10, 2024

    Report

    Report Number
    3010825766-2024-00004
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 9, 2024
    Report Date
    January 22, 2025
    Manufacturer
    INPECO SA
    Product Code
    JQP
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE INVESTIGATION CONDUCTED BY INPECO UP TO NOW, IT SEEMS THAT IN CASE OF TEST RESULTS MANUALLY SENT IN BATCH MODE FROM THE G11 ANALYZER TO FLEXLAB DMS, THE G11 ANALYZER SENDS ALL THE RESULTS TO DMS BUT DMS STORES ONLY ONE RESULT: SPECIFICALLY, DMS STORES THE RESULT OF THE LATEST SAMPLE TUBE ID RECEIVED BY DMS ASSOCIATING IT ERRONEOUSLY TO THE FIRST SAMPLE TUBE ID. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    THE BUG OCCURS WHEN: 1) THE ANALYZER DOES NOT SEND MULTIPLE RESULTS TO DMS BUT IT CONTINUES TO SAMPLE TUBES, AND 2) WHEN THE COMMUNICATION IS RESTORED, THE OPERATOR MANUALLY SENDS ALL THE RESULTS NOT YET TRANSMITTED TO DMS IN A SINGLE TRANSMISSION (BATCH MODE) FROM THE G11 ANALYZER TO FLEXLAB DMS. IN THESE CONDITIONS, THE G11 ANALYZER SENDS ALL THE RESULTS TO DMS BUT DMS STORES ONLY ONE RESULT: SPECIFICALLY, DMS STORES THE RESULT OF THE LATEST SAMPLE TUBE ID RECEIVED BY DMS ASSOCIATING IT ERRONEOUSLY TO THE FIRST SAMPLE TUBE ID. HOWEVER, THE INSTRUMENT SENDS THE NUMERIC RESULTS AND THE RELATIVE CHART SEPARATELY. THE NUMERIC RESULTS ARE AFFECTED BY THE BUG, BUT THE CHART DISPLAYED IN DMS INTERFACE IS CORRECT SO IN THE VALIDATION PHASE THE USER CAN DETECT THE MISMATCH. BESIDES THAT, THE INSTRUMENT PRODUCES PAPER TICKETS WITH THE CORRECT INFORMATION. THE OPERATOR CAN SO BECOME AWARE OF THE NUMERIC RESULT MISMATCH IN DMS SINCE THE TEST TYPE REQUIRES EVALUATION OF NUMERIC RESULTS TOGETHER WITH THE CHART. FOR THESE REASONS, INPECO HAS EVALUATED THAT A REOCCURRENCE OF THE EVENT HAS A NEGLIGIBLE LIKELIHOOD TO LEAD TO DEATH OR SERIOUS DETERIORATION IN PATIENT STATE OF HEALTH.

    Description of Event or Problem · 0

    THE CUSTOMER NOTIFIED INPECO THAT THEY HAD AN INTERRUPTION OF INTERNET CONNECTION AND THUS THE LIS CONNECTION BETWEEN FLEXLAB DMS AND THE G11 ANALYZERS WAS DOWN FOR A WHILE. IN THE MEANTIME, A FEW SAMPLES WERE ANALYZED BY THE G11 ANALYZER ITSELF. AFTER RE-ESTABLISHING THE CONNECTION, THE CUSTOMER TRIED TO MANUALLY SEND TO FLEXLAB DMS SOFTWARE THE BATCH OF 5 PATIENT RESULTS PRODUCED BY G11 ANALYZERS DURING THE DISCONNECTION TIMEFRAME. ONLY 1 RESULT CAME IN DMS BUT IT WAS NOT CORRECT: THERE WAS A MIX-UP OF 2 PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335413 FLEXLAB LABORATORY AUTOMATION SYSTEM JQP INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown