BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 6379770 · Received March 6, 2017

    Report

    Report Number
    3010825766-2017-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 6, 2017
    Report Date
    March 6, 2017
    Manufacturer
    INPECO SA
    Product Code
    JQP
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INVESTIGATED BY INPECO, WHICH DETERMINED THAT THE ABNORMAL NUMBER OF CLOT DETECTION ERRORS AND THE SAMPLES DILUTION WERE DUE TO A LACK OF MAINTENANCE OF THE ALIQUOTER TUBING SYSTEM. THE ALIQUOTER SERVICE MANUAL IS REFERENCED IN THE FLEXLAB SERVICE MANUAL: THE MAINTENANCE INSTRUCTIONS CLEARLY INDICATES THE FREQUENCY OF ALIQUOTER TUBING SYSTEM REPLACEMENT ACCORDING TO THE TIME PASSED SINCE THE INSTALLATION OR THE PREVIOUS REPLACEMENT OR THE OPERATING HOURS. THE MALFUNCTION WAS NOT DUE TO THE ALIQUOTER MODULE DESIGN. THIS DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR SERVICE TEAM HAS BEEN CONTACTED BY THE LABORATORY PERSONNEL DUE TO AN ABNORMAL NUMBER OF CLOT DETECTION ERRORS ON SAMPLES PROCESSED ON ALIQUOTER MODULE #1 (AQM # 1) CONNECTED TO FLEXLAB PRODUCT. DURING THE TROUBLESHOOTING A VIDEO WAS TAKEN TO AID WITH IDENTIFYING THE CAUSE OF THE PROBLEM: IT WAS DETERMINED FROM THE VIDEO THAT WATER FROM THE AQM #1 PIPETTOR CIRCUIT WAS BEING DISPENSED INTO THE SAMPLE TUBES. THE LABORATORY PERSONNEL AND THE DISTRIBUTOR SERVICE TEAM IDENTIFIED 175 PRIMARY SAMPLE TUBES AND 118 SECONDARY SAMPLE TUBES DILUTED DUE TO THE ALIQUOTER MODULE #1 MALFUNCTION. THERE WAS NO DEATH NEITHER SERIOUS INJURY TO ANY PATIENT DUE TO ERRONEOUS TEST RESULTS. AS IMMEDIATE ACTIONS THE ALIQUOTER MODULE #1 WAS SET OFF-LINE AND THE TESTS WERE RE-EXECUTED ON ALTERNATE SAMPLE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164882 FLEXLAB LABORATORY AUTOMATION SYSTEM JQP INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1