BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 9792268 · Received March 5, 2020

    Report

    Report Number
    3010825766-2020-00003
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 6, 2020
    Report Date
    September 28, 2020
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR 3010825766-2020-00003 WAS SUBMITTED ON MARCH 5TH, 2020. NEW INFORMATION: THE FSE REPEATED THE BLOOD TESTS AFTER 3 AND 6 MONTHS. THE RESULTS WERE NEGATIVE FOR INFECTIONS. THE EVENT HAS BEEN CONSIDERED AS A HUMAN ERROR AND NO DESIGN CHANGES ARE FORESEEN.

    Additional Manufacturer Narrative · 1

    THE LABELING HAS BEEN REVIEWED AND CONSIDERED APPROPRIATE. IN THE OPERATIONS MANUAL IT HAS ALREADY RECOMMENDED TO USE CAUTION WHEN ACCESSING PARTS OF THE MODULE NORMALLY PROTECTED BY COVERS SINCE SHARP SURFACES CAN BE REACHED. IN THE COBAS 8000 INTERFACE MODULE SECTION THERE IS A WARNING TO ADVISE THE OPERATORS ABOUT THE CUTTING HAZARD DUE TO THE SHARP SURFACE OF THE ROBOT GRIPPER.THE HEALTH CONDITIONS OF THE FSE WILL BE KEPT MONITORED.

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER GOT A CUT ON HIS HAND WHILE HE WAS WORKING ON THE COBAS 8000 INTERFACE MODULE (IM) TO FIX A MALFUNCTION OF THE IM ROBOT GRIPPER WHICH MOVES UNCAPPED TUBES. WHEN THE INJURY OCCURRED THE FSE WAS WEARING PPE, BUT THE GRIPPER FINGERS PIERCED THE GLOVES. THE CUT WAS DISINFECTED AND BANDAGED. A BLOOD TEST WAS IMMEDIATELY PERFORMED: ALL TEST RESULTS WERE NEGATIVE. THE BLOOD TESTS WILL BE REPEATED AFTER 3 MONTHS AND 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255009 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1