BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 17708769 · Received September 8, 2023

    Report

    Report Number
    3010825766-2023-00009
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    July 15, 2023
    Report Date
    December 20, 2023
    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

    SPLASHING ISSUE WAS IDENTIFIED ON SEVERAL TBMS ON BOTH SYSTEMS: FLX.0197 AND FLX.0198. THE SERVICE PERSONNEL, GUIDED BY INPECO, CHECKED THE TBMS (E.G. TRANSITION OF CARRIERS TO THE TURN DISK, SPINNING TIME OF T-MODULE DISK ETC.). THE SERVICE PERSONNEL PERFORMED TROUBLESHOOTING PROCEDURES ACCORDING TO INDICATIONS GIVEN IN THE SERVICE MANUAL (E.G. NSD DEVICE ALIGNMENT) ON ALL TBMS. IN ADDITION THE SERVICE PERSONNEL REPLACED POLYCORD BELTS AND DISK ON ONE TBM, AND REPLACED THE TBM WITH A STRAIGHT TRACK BEING THE TBM UNNECESSARY FOR THE SAMPLE TUBES ROUTING IN THIS SPECIFIC LAYOUT SECTION. THE DISTRIBUTOR, THAT IS ALSO THE PROVIDER OF SERVICE SUPPORT AT THE CUSTOMER LOCATION, CONFIRMED THAT THE SPLASHING ISSUE HAS BEEN SOLVED. NO OTHER ACTIONS FORESEEN AT THIS CUSTOMER. INPECO HAS EVALUATED THAT NO FURTHER ACTION ON FIELD IS NEEDED, AS THE DESIGN IS CONSIDERED ADEQUATE.

    Additional Manufacturer Narrative · 0

    ACCORDING TO INPECO INVESTIGATION THE SAMPLE ID (B)(6) WAS NEVER UNCAPPED, SO IT COULD NOT BE CONTAMINATED ON THE AUTOMATION SYSTEM. THE SAMPLE TUBE CONTAMINATED COULD BE SAMPLE ID (B)(6), BUT IT STILL TO BE CONFIRMED FROM THE FIELD. ACCORDING TO THE DATA ANALYZED, THE SAMPLE ID (B)(6) PASSED THROUGH ONE OF THE TBM WHERE SAMPLE SPILLAGE HAS BEEN FOUND. MOREOVER, THE SAMPLE TUBE HAS BEEN TESTED FOR THCG ON SIEMENS ATELLICA ANALYZER, GIVING THE INCORRECT RESULT. THE INCORRECT RESULT HAS BEEN QUESTIONED BY THE PHYSICIAN, AND NO HEALTH IMPACT ON THE PATIENT HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING TO DETERMINE THE CAUSE OF THE SPILLAGE.

    Description of Event or Problem · 0

    SAMPLE RESIDUES HAVE BEEN FOUND ON SEVERAL TRACK BYPASS MODULES (TBM) OF FLEXLAB AS RESULTS OF SAMPLE SPILLAGE. THE TBM IS A SECTION OF TRACK WHERE THE CARRIERS WHICH TRANSPORT THE SAMPLE TUBES ARE DIVERTED TO REACH MORE QUICKLY THE NEEDED MODULES/INTERFACE MODULES. THE POSSIBLE RISK ASSOCIATED TO THIS ISSUE IS THE CROSS-CONTAMINATION OF ANOTHER UNCAPPED TUBE IN THE AREA WHERE THE TUBE SPILLED. THE CUSTOMER REPORTED A CASE OF SAMPLE TUBE POTENTIALLY CONTAMINATED AT THE TBM#14 WITH CONSEQUENT INCORRECT RESULTS. ACCORDING TO THE CUSTOMER, THE SAMPLE TUBE WITH ID (B)(6) WAS TESTED FOR THCG (HUMAN CHORIONIC GONADOTROPIN), AND THE RESULT 111.10 WAS REPORTED AND QUESTIONED BY THE PHYSICIAN SINCE IT WAS NOT CONSISTENT WITH PATIENT HEALTH CONDITIONS. THE CUSTOMER USED ANOTHER SAMPLE TUBE OF THE SAME PATIENT TO REPEAT THE ANALYSIS ON ANOTHER SIEMENS ATELLICA ANALYZER, RESULTING IN <2. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614418 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA 07640172340004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown