BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATE 2550

    MDR report key: 16569801 · Received March 18, 2023

    Report

    Report Number
    3006655511-2023-00006
    Event Type
    Injury
    Date Received
    March 18, 2023
    Date of Event
    February 18, 2023
    Report Date
    November 6, 2023
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    CDD
    UDI-DI
    15099590364083
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT PROVIDE INFORMATION RELATING TO THE CHANGE IN PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE AUTOMATE 2550. THE LOG FILES FROM THE INSTRUMENT WERE REVIEWED. THE FSE AND APPLICATION SUPPORT MANAGER DETERMINED THAT THE FILES INDICATE THAT THE CUSTOMER MAY HAVE HAD TWO TUBES FROM TWO DIFFERENT PATIENTS. THE LOG FILES DID NOT INDICATE AN ISSUE WITH THE INSTRUMENT. THERE IS NO EVIDENCE OF A INSTRUMENT MALFUNCTION. THE CUSTOMER WAS SATISFIED WITH THE SUPPORT AND NO FURTHER ISSUES WERE REPORTED. INITIAL REPORTER TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SORTING DRIVE OF THEIR AUTOMATE 2550 IS ALIQUOTING THE WRONG TUBE AND STORING THE CORRECT TUBE WHICH RESULTED IN THE RELEASE OF FALSE TROPONIN PATIENT RESULTS. THE CUSTOMER REPORTED THAT THERE WAS A CHANGE IN PATIENT TREATMENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12834 AUTOMATE 2550 RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 2550 15099590364083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other