BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE (RADV)

    MDR report key: 9617299 · Received January 22, 2020

    Report

    Report Number
    3006543086-2020-00001
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    January 3, 2020
    Report Date
    January 22, 2020
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    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 SERVICE (CTS) EVALUATED THE EVENT, AND IDENTIFIED THE "VALIDATION RANGE" SETTINGS WERE INCORRECT. THE PATIENT WAS ONE (1) DAY OLD AND WAS NOT INCLUDED IN THE "LESS THAT 1 DAY OLD" VALIDATION RANGE. CTS CONFIRMED THAT THE RULES RAN AS EXPECTED BASED ON THE "VALIDATION RANGE" SETTINGS. THE SETTINGS WERE ADJUSTED TO RESOLVE THE ISSUE. AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION NOT PROVIDED BY CUSTOMER. (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CRITICAL TBIL (TOTAL BILIRUBIN) RESULTS FOR AN INFANT WERE AUTO VALIDATED BY REMISOL ADVANCE (RADV) WHEN IT SHOULD HAVE NOT BEEN AUTO VALIDATED, WHICH CAUSED A DELAY IN PATIENT TREATMENT BY ONE (1) DAY. THERE WAS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79998 REMISOL ADVANCE (RADV) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. WORK STATION, US HW, RADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other