BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 18844203 · Received March 6, 2024

    Report

    Report Number
    3010825766-2024-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 27, 2024
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172340004
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SUBMITTED ON MARCH 6TH, 2024. ADDITIONAL INFORMATION: INPECO COMPLETED THE INVESTIGATION CHECKING THE ALIQUOTER MODULE CONFIGURATIONS AND CONFIRMED THAT THE SET PARAMETERS ARE CORRECT. THE DISTRIBUTOR ALREADY CHECKED THE ALIQUOTER MODULE ON SITE: NO PROBLEMS WERE IDENTIFIED AND NO ACTIONS OR REPAIRS WERE REQUIRED. THE INVESTIGATION HAS NOT IDENTIFIED ANY ISSUE IN THE ALIQUOTER MODULE WHICH IS WORKING AS EXPECTED. THERE IS NO REASON TO SUSPECT THAT THE ALIQUOTER MODULE HAS DILUTED THE SECONDARY TUBE. NO ADDITIONAL ACTIONS ARE FORESEEN.

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR DIRECTLY INVESTIGATED THE EVENT CHECKING THE ALIQUOTER MODULE WHEN THE PROBLEM WAS REPORTED. NO PROBLEMS WERE IDENTIFIED AND NO ACTIONS OR REPAIRS WERE REQUIRED. INPECO IS CONTINUING THE INVESTIGATION TO DETERMINE IF THE ALIQUOTER MODULE CONTRIBUTED TO THE EVENT DILUTING THE DAUGHTER TUBE.

    Description of Event or Problem · 0

    A US CUSTOMER REPORTED THAT AN ERRATIC RESULT WAS OBTAINED FROM AN ALIQUOTED TUBE GENERATED ON THE FLEXLAB AUTOMATION SYSTEM. THE MOTHER TUBE WAS LOADED ON THE AUTOMATION SYSTEM: THE VOLUME WAS EVALUATED SUFFICIENT, SO THE TUBE WAS DIVERTED TO THE ALIQUOTER MODULE (ALQ). A SINGLE DAUGHTER TUBE WAS GENERATED WITHOUT ANY ERROR MESSAGE. THE DAUGHTER TUBE WAS RECAPPED AND UNLOADED TO BE TESTED FOR THE ANTINUCLEAR ANTIBODY (ANA) ASSAY OFF-TRACK. A NEGATIVE RESULT WAS OBTAINED. THE RESULT WAS CHALLENGED BY THE DOCTOR WHO ORDERED A RERUN ON THE MOTHER TUBE AND ON ANOTHER PRIMARY TUBE OF THE SAME PATIENT. BOTH THE RESULTS WERE POSITIVE. THE CUSTOMER NOTED THE COLOR OF THE SERUM IN THE DAUGHTER TUBE SEEMED CLEAR AND SUSPECTED IT MAY HAVE BEEN DILUTED WITH THE WATER OF THE ALQ TUBE SYSTEM WITHOUT ANY WARNING. BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER, NO HARM CAME TO THE PATIENT AND NO DELAY IN TREATMENT OCCURRED. THE CUSTOMER ALSO REQUESTED A CHECK OF THE SAMPLE TUBES MANAGED BY THE ALIQUOTER MODULE BEFORE AND AFTER THE IMPACTED MOTHER TUBE AND NO PROBLEMS WITH RESULTS WERE IDENTIFIED FOR THOSE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118456 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA 07640172340004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown