BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 12211406 · Received July 22, 2021

    Report

    Report Number
    3010825766-2021-00009
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Report Date
    July 22, 2021
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION SHOWED THAT THE ISSUE IS RELATED TO A MECHANICAL PROBLEM AT THE UNLOAD GATE. THE SERVICE AGENCY HAS REPLACED THE ELECTROVALVE AND THE MANIFOLD WHICH CONTROL THE OPENING AND THE CLOSURE OF THE UNLOAD GATE. AFTER THE SERVICE INTERVENTION, NO FURTHER OCCURRENCES HAVE BEEN OBSERVED. THE MODULE IS NOW WORKING ACCORDING TO SPECIFICATION SO NO ADDITIONAL ACTION IS FORESEEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CASES OF SAMPLE SPILLAGE AT THE INPUT OUTPUT MODULE (IOM). THE IOM IS A MODULE OF THE AUTOMATION SYSTEM DESIGNED TO LOAD AND UNLOAD THE SAMPLE TUBES FROM THE RACKS TO THE AUTOMATION SYSTEM TRACK AND VICE VERSA. THE IMPACTED SAMPLE TUBES WERE STOPPED IN THE IOM UNLOAD POSITION BY THE UNLOAD GATE TOO FAR AHEAD AND THE GRIPPER OF THE IOM ROBOT ARM DID NOT CORRECTLY GRAB THE SAMPLE TUBE CAUSING SOME SAMPLE SPILLAGE. THE MODULE STOPPED WORKING GENERATING THE ERROR MESSAGE 04B5 (SAMPLE TUBE NOT FOUND WHERE EXPECTED) WHICH REQUIRED THE OPERATOR INTERVENTION ON THE MODULE. IN THE MEANTIME THE IMPACTED CARRIERS REACHED THE NEXT GATE IN THE IOM BUFFER. THE SAMPLE SPILLAGE MAY CAUSE CROSS CONTAMINATION IF THE SAMPLE DROPS FALL INTO ANOTHER UNCAPPED SAMPLE TUBE PRESENT IN THE AREA. THE INVESTIGATION DID NOT PROVIDE ANY EVIDENCE OF CROSS CONTAMINATION. NO DISCREPANT TEST RESULTS POTENTIALLY CAUSED BY SAMPLE CROSS CONTAMINATION HAVE BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109296 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other