BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMEK NXP SPAN-8 WITHOUT GRIPPER

    MDR report key: 11612075 · Received April 4, 2021

    Report

    Report Number
    1061932-2021-00050
    Event Type
    Malfunction
    Date Received
    April 4, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 4, 2021
    Manufacturer
    BECKMAN INSTRUMENTS INC.
    Product Code
    JJG
    UDI-DI
    15099590440893
    PMA / PMN Number
    K903626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO IMPACT TO PATIENTS AS A RESULT OF THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND CONFIRMED WHAT THE CUSTOMER REPORTED. THE ISSUE WAS FOUND TO BE IN THE BIOMEK INSTRUMENT WHERE THE SAMPLES WERE PROCESSED PREVIOUS TO RUNNING THEM ON THE FC 500 FLOW CYTOMETER RESULTING IN THE ERRONEOUS RESULTS BEING GENERATED. THE FC 500 WAS RUNNING WITHOUT ISSUE. IT WAS FOUND THAT THE BIOMEK INSTRUMENT HAD A BLOCKED PIERCING PROBE CAUSING THE SAMPLES TO BE IMPROPERLY PREPARED PREVIOUS TO RUNNING THEM ON THE FC 500. THE FSE REPLACED THE PIERCING PROBE ON THE BIOMEK TO RESOLVE THE REPORTED ISSUE. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SAMPLES PREPPED ON THE BIOMEK GENERATED ERRONEOUSLY HIGH WHITE CELL COUNTS WHEN ANALYZED ON THE FC500 FLOW CYTOMETER (P/N 626554). DATA PROVIDED CONFIRMS AND ALSO SHOWS ERRONEOUSLY HIGH CD4+ RESULTS. THE ERRONEOUS RESULTS WERE IDENTIFIED AND NOT REPORTED OUT OF THE LABORATORY. THE PATIENT SAMPLES WERE PROCESSED ON A DIFFERENT BIOMEK AND THE RESULTS CONSIDERED CORRECT WERE REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509246 BIOMEK NXP SPAN-8 WITHOUT GRIPPER ANALYZER, CHEMISTRY, CENTRIFUGAL, FOR CLINICAL USE JJG BECKMAN INSTRUMENTS INC. BIOMEK NXP SPAN-8 WITHOUT GRIPPER 15099590440893

    Patients

    Seq Age Sex Outcome Treatment
    1