BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE VIRTUALIZED SERVER 2012

    MDR report key: 16128159 · Received January 9, 2023

    Report

    Report Number
    3006543086-2023-00005
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 9, 2023
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BECKMAN CUSTOMER TECHNICAL SPECIALIST (CTS) PERFORMED TROUBLESHOOTING AND DETERMINED THE CAUSE WAS DUE TO THE CUSTOMER INCORRECTLY MODIFYING THE PARAMETERS CAUSING SYSTEM TO UNNECESSARILY DILUTE THE PATIENT SAMPLES. CTS INSTRUCTED THE CUSTOMER TO REVISE THE RULE SETTING TO RESOLVE THE ISSUE. THE CUSTOMER HAS NOT CALLED BACK FOR ANY FURTHER ISSUES REGARDING THIS EVENT. SYSTEM RESUMED NORMAL OPERATION. THERE IS NO EVIDENCE OF A REMISOL SYSTEM MALFUNCTION. PT INFO. INFORMATION NOT PROVIDED BY CUSTOMER. NO UDI AVAILABLE AS THERE IS NO SERIAL NUMBER PROVIDED FOR A VIRTUAL SERVER MFR SITE, REPORTING CONTACT TELEPHONE NUMBER IS (B)(4). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE GENERATION OF INCORRECT FERRITIN RESULTS FOR TWO (2) PATIENTS DUE TO AUTO DILUTION RULE IN THE REMISOL SYSTEM. THE INCORRECT PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. TWO (2) PATIENTS WERE GIVEN TREATMENT AS A RESULT. THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION FOR THIS EVENT. THE CUSTOMER INDICATED THE CORRECTED RESULTS WERE LATER REPORTED. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. CUSTOMER DID NOT PROVIDE PATIENTS DATA OR DEMOGRAPHICS. THIS MDR WILL ADDRESS CHANGE IN TREATMENT FOR PATIENT #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254871 REMISOL ADVANCE VIRTUALIZED SERVER 2012 CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. REMISOL ADVANCE VIRTUALIZED SERVER 2012 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other