BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORK STATION, OPTIPLEX7050, HW, RADV

    MDR report key: 12457414 · Received September 10, 2021

    Report

    Report Number
    3006543086-2021-00003
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 19, 2021
    Report Date
    September 10, 2021
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    UDI-DI
    15099590704223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) REMOTELY CONNECTED TO REMISOL AND CHECKED THE EXAMPLE THAT WAS PROVIDED BY THE CUSTOMER. CTS SHOWED THE CUSTOMER THAT THERE WERE CRITICAL RESULTS AND BASED ON THE RULES, REMISOL WILL NOT UPLOAD CRITICAL RESULTS UNLESS THE TECHNICIAN UPLOADS THEM MANUALLY. CTS SHOWED THE CUSTOMER THAT THE TECHNICIAN UPLOADED THE RESULTS ABOUT AN HOUR AFTER THE RESULTS CAME TO REMISOL. THE ISSUE WAS DUE TO A USE ERROR. CUSTOMER AGREED WITH THE FINDINGS AND STATED THAT THEY WILL COMMUNICATE WITH THE TECHNICIAN AS TO WHY IT TOOK AN HOUR TO UPLOAD THE RESULTS. DELAYED RESULT CAUSED DELAYED PATIENT DISCHARGE FROM THE HOSPITAL. THERE WAS NO IMPACT TO THE PATIENT DIAGNOSTICS OR TREATMENT. AGE OR DOB, WEIGHT, ETHNICITY: INFORMATION NOT PROVIDED BY CUSTOMER. PHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT QUESTIONED HOSPITAL ABOUT RESULT RECEIVED TO THE REMISOL WHICH WAS DELAYED TO REACH LIS (LABORATORY INFORMATION SYSTEM). THERE IS NO REPORT OF ERRONEOUS RESULT GENERATED OR REPORTED OUT OF THE LAB. THE RESULT WAS ONE HOUR DELAYED REACHING TO LIS. DELAYED RESULT CAUSED DELAYED PATIENT DISCHARGE FROM THE HOSPITAL. THERE WAS NO IMPACT TO THE PATIENT DIAGNOSTICS OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351564 WORK STATION, OPTIPLEX7050, HW, RADV CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. WORK STATION, OPTIPLEX7050, HW, RADV 15099590704223

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization