BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSY MAIN PRIMARY DRIVE DUAL

    MDR report key: 22145759 · Received June 4, 2025

    Report

    Report Number
    3006655511-2025-00005
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    CDD
    UDI-DI
    15099590719654
    PMA / PMN Number
    K190298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TROUBLESHOOTING WITH A BECKMAN CUSTOMER TECHNICAL SPECIALIST FOUND THE SAMPLE HAD BEEN REMOVED FROM THE DXA SYSTEM. NO ERRORS WERE REPORTED BY THE CENTRIFUGE OR TRANSPORT SYSTEM. THE SAMPLE SUCCESSFULLY PROCESSED WITH NORMAL RESULTS AFTER BEING RELOADED. BASED ON THE CURRENT INFORMATION, THERE'S INSUFFICIENT EVIDENCE OF A SYSTEM MALFUNCTION, AND THE PROBABLE CAUSE IS UNKNOWN. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A ROUTING ISSUE ON THEIR DXA TRANSPORT SYSTEM CAUSED A PATIENT SAMPLE TO REMAIN IN THE ADAPTER SHUTTLE, DELAYING RESULTS. THIS WAS DISCOVERED WHEN RESULTS WERE REQUESTED. THE SAMPLE WAS MANUALLY FRONT-LOADED AND PROCESSED WITH NORMAL RESULTS. THIS DELAY IMPACTED PATIENT MANAGEMENT, SPECIFICALLY CAUSING A DELAY IN CHEMOTHERAPY TREATMENT, THOUGH THE PATIENT WAS NOT HARMED. NO FURTHER DETAILS WERE PROVIDED. THE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852404 ASSY MAIN PRIMARY DRIVE DUAL RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER BIOMEDICAL GMBH ASSY MAIN PRIMARY DRIVE DUAL - TRAN N/A 15099590719654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other