BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE (RADV)

    MDR report key: 11499664 · Received March 16, 2021

    Report

    Report Number
    3006543086-2021-00001
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 16, 2021
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE ISSUE OCCURRED SINCE ONE SUPERVISOR INCORRECTLY ACTIVATED NEW PROGESTERONE RULES SETTING IN REMISOL ADVANCE (RADV). BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT/HOLTINE) REVIEWED PATIENT DATA AND CONFIRMED THE INCORRECT SETTING. THE CUSTOMER DEACTIVATED THE ERRONEOUS PROGESTERONE RULES TO RESOLVE THE ISSUE. AGE/DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION NOT PROVIDED BY THE CUSTOMER. REPORTING CONTACT TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMISOL ADVANCE (RADV LIS: LABORATORY INFORMATION SYSTEM) RELEASED FALSE LOW PROGESTERONE RESULTS FOR FIVE (5) PREGNANT PATIENT SAMPLES. THE RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF INJURY OR DEATH; NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT. TWO (2) PATIENTS WERE PRESCRIBED TO TAKE MORE PROGESTERONE TO THEIR DAILY DOSAGE. THE RESULTS WERE AMENDED AND THE TWO (2) PATIENTS WERE ADVISED TO LOWER THEIR DOSES. THERE WAS NO REPORT OF IMPACT ON PATIENT'S TREATMENT OR PATIENT'S HEALTH FOR THE OTHER THREE (3) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393807 REMISOL ADVANCE (RADV) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. SERVER, DELL T310, WIN 2008 OS, REMISOL ADVANCE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other