BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 10122111 · Received June 5, 2020

    Report

    Report Number
    3010825766-2020-00005
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    April 18, 2020
    Report Date
    June 5, 2020
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INVESTIGATION, THE EVENTS OF DILUTED SECONDARY TUBES NOT FLAGGED WITH 2132 ERROR ARE ATTRIBUTABLE TO THE DYE WHICH IS NOT ALLOWED ACCORDING TO THE ALIQUOTER PIPETTOR INSTRUCTION FOR USE. THE ADDITION OF LIQUIDS DIFFERENT FROM DISTILLED WATER CAN DAMAGE THE COMPONENTS OF THE ALIQUOTER PIPETTOR AND CAN LEAD TO INACCURATE VOLUMES DURING THE ASPIRATION AND THE DISPENSING. THE CASES OF DILUTION AFTER THE ADDITION OF THE DYE ARE CAUSED ONLY BY THE INAPPROPRIATE USE OF THE ALIQUOTER MODULE. THE DISTRIBUTOR FSE HAS CHANGED THE DAMAGED PARTS, HAS REMOVED THE DYE, HAS WASHED THE ALIQUOTER HYDRAULIC CIRCUIT AND HAS FILLED IT WITH THE CORRECT LIQUID (DISTILLED WATER). AFTER THESE OPERATIONS, THE DISTRIBUTOR FSE CONFIRMED THAT THE ALIQUOTER MODULE IS WORKING ACCORDING TO SPECIFICS. AS CONSEQUENCE OF THIS EVENT, INPECO IS REVIEWING THE MESSAGE DISPLAYED ON THE GRAPHIC INTERFACE FOR THE ERROR 2132 TO CLARIFY TO THE USER THAT THE SECONDARY SAMPLE FLAGGED WITH THIS ERROR MAY BE DILUTED. INPECO HAS PLANNED A NEW TRAINING OF THE DISTRIBUTOR REGARDING THE NEW MANAGEMENT OF THE CLOT DETECTION ERROR SO THAT THEY CAN BETTER INFORM THE CUSTOMERS.

    Description of Event or Problem · 1

    INPECO AUTOMATION SYSTEM INCLUDES THE ALIQUOTER MODULE WHICH IS USED TO GENERATE SECONDARY SAMPLE TUBES FROM THE PRESENTED PRIMARY SAMPLE TUBE. IN THIS LABORATORY THE ALIQUOTER MODULE HAS BEEN UPDATED IN ACCORDANCE TO RECALL CURRENTLY IN PROGRESS (RES 85469). THE UPGRADE INCLUDES THE NEW MANAGEMENT OF THE CLOT DETECTION ERROR: IN CASE A CLOT DETECTION ERROR IS GENERATED DURING THE ASPIRATION, THE SAMPLE IS DISPENSED IN THE FIRST AVAILABLE EMPTY SECONDARY TUBE. THIS SECONDARY TUBE IS FLAGGED WITH A SPECIFIC ERROR (2132) AND SENT TO A RACK OF THE INPUT OUTPUT MODULE TO BE MANUALLY MANAGED BY THE OPERATOR. IN CASE THE ALIQUOTER CANNOT ASPIRATE THE CORRECT SAMPLE VOLUME, IT MAY DISPENSE, BESIDES THE ASPIRATED SAMPLE, ALSO SOME DISTILLED WATER OF THE ALIQUOTER MODULE HYDRAULIC CIRCUIT. SINCE THE CUSTOMER WAS NOT AWARE OF THE NEW BEHAVIOR OF THE ALIQUOTER MODULE, HE SUSPECTED THAT THE ALIQUOTER MODULE UNEXPECTEDLY DILUTED THE SECONDARY TUBES. TO MONITOR THE ALIQUOTER MODULE THE DISTRIBUTOR FSE ADDED A DYE IN THE MODULE HYDRAULIC CIRCUIT. AFTER THIS ADDITION, ON MAY 7TH 2020, THE CUSTOMER REPORTED OTHER CASES OF DILUTION OF SECONDARY TUBES ALSO NOT FLAGGED WITH 2132 ERROR. SINCE THESE CASES WERE NOT THE EXPECTED BEHAVIOR OF THE ALIQUOTER MODULE, THEY HAVE BEEN INVESTIGATED BY INPECO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585832 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other