BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXA-INPUT-OUTPUT-DEC

    MDR report key: 18576779 · Received January 24, 2024

    Report

    Report Number
    3006655511-2024-00001
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    December 19, 2023
    Report Date
    October 9, 2024
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    CDD
    UDI-DI
    15099590739942
    PMA / PMN Number
    K190298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN TIGHTENING THE LOCK NUT TO THE ANALYZER FEET, FSE WAS INJURED WITH LACERATION ON THE RIGHT WRIST. THE FSE VISITED THE EMERGENCY ROOM AND RECEIVED TREATMENT. THE FSE EVALUATED THE ANALYZER AND FOUND NO EVIDENCE OF A HARDWARE MALFUNCTION. BASED ON THE AVAILABLE INFORMATION SUGGESTS THIS WAS AN ACCIDENTAL INJURY. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. BECKMAN COULTER INTERNAL IDENTIFIER IS CASE (B)(4).

    Additional Manufacturer Narrative · 0

    UPON ADDITIONAL REVIEW, IT WAS DETERMINED THE BECKMAN FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND FOUND NO EVIDENCE OF BECKMAN ANALYZER MALFUNCTION. NO HARDWARE PARTS WERE REPLACED. THE REPORTED INJURY WAS A RESULT OF A WRENCH HITTING THE RIGHT-HAND WRIST. BASED ON THE AVAILABLE INFORMATION SUGGESTED THIS EVENT WAS AN ACCIDENTAL INJURY. THE FSE REPORTED NO FURTHER ISSUES DUE TO THE EVENT. THIS IS NOT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE BECKMAN FIELD SERVICE ENGINEER (FSE) REPORTED A LACERATION ON THE RIGHT WRIST DURING AN INSTALLATION OF THE DXA ANALYZER. THE INCIDENT OCCURRED WHEN FSE WAS TIGHTENING THE LOCKNUT WITH A WRENCH AND THE WRENCH SLIPPED. THE FSE WAS WEARING GLOVES AT THE TIME OF THE INJURY. THE FSE APPLIED A BAND-AID TO STOP THE BLEEDING AND WENT TO EMERGENCY ROOM FOR TREATMENT OF THE LACERATION. THE FSE WAS NOT PRESCRIBED ANY MEDICATION AND DID NOT MISS ANY WORK DUE TO THE INJURY. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122703 DXA-INPUT-OUTPUT-DEC RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER BIOMEDICAL GMBH DXA-INPUT-OUTPUT-DEC N/A 15099590739942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other