BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORK STATION OPTIPLEX7050 HW RADV

    MDR report key: 14197775 · Received April 25, 2022

    Report

    Report Number
    3006543086-2022-00002
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 25, 2022
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    UDI-DI
    15099590704223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BECKMAN NATIONAL PRODUCT SPECIALIST EVALUATED THE REMISOL RULES AND NOTICED THAT THE RULE FOR HOLDING SAMPLE WITH SAMPLE ID 'XX' WAS NOT SET. THE BECKMAN NATIONAL PRODUCT SPECIALIST ENTERED THE REMISOL RULES TO HOLD SAMPLES WITH SAMPLE ID ¿XX¿ TO RESOLVE THE ISSUE. CUSTOMER PERFORMED TESTING AND THE RULES PLAYED AS EXPECTED. PT INFO: INFORMATION NOT PROVIDED BY CUSTOMER. PHONE NUMBER IS (B)(4). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED PATIENT SAMPLES DID NOT GET RECEIVED WITH DEMOGRAPHICS AND SHOWED UP IN REMISOL WITH PATIENT ID STARTING WITH ¿XX¿. THE PATIENT SAMPLES DID NOT HOLD UP IN REMISOL FOR REVIEW. IT WAS REPORTED THAT ONE PATIENT SAMPLE RESULT WAS DELAYED AND RESULTED IN DELAY OF SURGERY. THERE WAS NO REPORT OF HARM TO THIS PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS. THE CUSTOMER ONLY PROVIDED THE IDENTIFICATION NUMBER FOR THIS PATIENT SAMPLE, SAMPLE ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774291 WORK STATION OPTIPLEX7050 HW RADV CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. WORK STATION OPTIPLEX7050 HW RADV N/A 15099590704223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other