BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 16681197 · Received April 5, 2023

    Report

    Report Number
    3010825766-2023-00005
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    February 24, 2023
    Report Date
    May 15, 2023
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT (MDR 3010825766-2023-00005) WAS SUBMITTED ON APRIL 5TH, 2023. ADDITIONAL INFORMATION: THE DISTRIBUTOR FSE ADJUSTED THE TRACK QUEUE LENGTH ACCORDING TO INPECO'S INDICATIONS AND REPLACED THE DEFECTIVE STOP GATE. THE FSE ALSO READJUSTED LAVI TUNNEL POSITION TO ALLOW BETTER EXIT FOR THE CARRIERS WITH SAMPLE TUBES. AFTER THESE ACTIVITIES, THERE HAVE BEEN NO CARRIER FLOW ISSUES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A POTENTIAL SAMPLE ID MISMATCH DUE TO WRONG ASSIGNMENT OF A SAMPLE TUBE TO A CARRIER INSIDE THE LATERAL VISION SYSTEM (LAVI) OF THE RACK INPUT MODULE (RIM). THE LAVI IS THE COMPONENT OF THE RIM THAT ALLOWS THE SAMPLE ID READING AND TUBE TYPE IDENTIFICATION. THE CUSTOMER NOTICED THE ERROR AND RETRIEVED BOTH THE INVOLVED SAMPLE TUBES. HE DID NOT REPORT ANY CONSEQUENCE ON THE STATE OF HEALTH OR MEDICAL TREATMENT OF THE INVOLVED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211721 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown