BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLEX 2200

    MDR report key: 15629585 · Received October 18, 2022

    Report

    Report Number
    1000135116-2022-00001
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    August 18, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    NSU
    UDI-DI
    00847865002813
    PMA / PMN Number
    BK140112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BIOPLEX 2200 IS CONNECTED TO INPECO LABORATORY AUTOMATION SYSTEM (TLA) AT (B)(6) IN NORWAY. ON SEPT 15TH, 2022, A REQUEST CAME FROM (B)(4)(DISTRIBUTOR OF THE INPECO TLA IN NORWAY) TO ACCESS THE COMMUNICATION LOGS BETWEEN BIOPLEX AND TLA BECAUSE OF AN ERROR AT THE ASPIRATION POSITION OF THE TLA, A SAMPLE TUBE BECAME STUCK IN THE TRACK LINE AT THE BIOPLEX GATING AREA. THE BIOPLEX PIPETTED FROM THE TUBE SEVERAL TIMES AND MISASSIGNED THE SAMPLE TO SUBSEQUENT ACCESSION NUMBERS. (B)(4) HAS CONFIRMED THAT THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED. THE LABORATORY RETESTED THE SAMPLES WITHOUT RECURRENCE OF INCIDENT. ON SEPTEMBER 19TH, BIO-RAD TECHNICAL SUPPORT PERSONNEL ESCALATED THE CASE AS A POTENTIAL ADVERSE EVENT. SOFTWARE ENGINEERS FROM INPECO AND BIO-RAD ARE EVALUATING EVENT LOGS AND INVESTIGATING THE ROOT CAUSE FOR THIS ISSUE.

    Description of Event or Problem · 0

    THE BIOPLEX IS CONNECTED TO A INPECO LABORATORY AUTOMATION SYSTEM (TLA). DUE TO AN ERROR AT THE ASPIRATION POSITION OF THE TLA, A SAMPLE TUBE BECAME STUCK IN THE TRACK LINE AT THE BIOPLEX GATING AREA. THE BIOPLEX PIPETTED FROM THE TUBE SEVERAL TIMES AND MISASSIGNED THE SAMPLE TO SUBSEQUENT ACCESSION NUMBERS. THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224339 BIOPLEX 2200 INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS NSU BIO-RAD LABORATORIES, INC BIOPLEX 2200 N/A 00847865002813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other