BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 19936807 · Received August 8, 2024

    Report

    Report Number
    3010825766-2024-00003
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 8, 2024
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172340004
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE ANALYSIS, THE RESUSPENSION OF THE CORPUSCULAR CELLS IS NOT DUE TO THE ABRUPT ASPIRATION PHASE, BUT DUE TO THE PRE-MIXING OPTION, AVAILABLE BY DEFAULT ON THE PIPETTOR OF THE ALIQUOTER MODULE. THE ALIQUOTS ARE TESTED ON A THIRD PARTY INSTRUMENT FOR COAGULATION TESTS. THE RESULTS COULD BE ALTERED BY THE PRESENCE OF CELLS (E.G. PLATELETS) IMPACTING THE PRECISION OF THE TEST. THE ROOT CAUSE OF THE EVENT IS THE PRE-MIXING OPTION OF THE ALIQUOTER MODULE'S PIPETTOR. THE PRE-MIXING OPTION HAS BEEN DISABLED IN THE NEW FIRMWARE VERSION OF THE ALIQUOTER MODULE, IN ORDER TO AVOID THE PRE-MIXING STEP BEFORE THE ASPIRATION AND DISPENSING PROCESS. THE NEW FIRMWARE HAS BEEN RELEASED BY INPECO, AND INSTALLED IN THE LABORATORY IMPACTED BY THE ISSUE. THE LABORATORY IMPACTED BY THE ISSUE IS THE ONLY CUSTOMER HAVING INSTALLED THE ALIQUOTER MODULE WITH THE FIRMWARE VERSION AFFECTED BY THE PROBLEM, AND USING THE ALIQUOTER MODULE FOR DIAGNOSTIC PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE ASPIRATION OF THE ROBOT OF THE ALIQUOTER MODULE OF FLEXLAB IS QUITE ABRUPT, AND CAUSES TURBULENCE IN THE SAMPLE TUBE.THE CITRATE TUBES FOR THE COAGULATION DON'T HAVE A GEL LAYER; THEREFORE THE CENTRIFUGED CELLS CAN BE RESUSPENDED IF THE ASPIRATION FORCES ARE TOO STRONG.THE CONSEQUENCE IS THE CREATION OF ALIQUOTS CONTAINING CORPUSCOLAR PARTICLES, THAT COULD GIVE INCORRECT RESULTS, AS THE CELLS ARE MEASURED ALONG WITH THE PLASMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395120 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA 07640172340004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other