BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSELECT ADS SYSTEM

    MDR report key: 19183687 · Received April 24, 2024

    Report

    Report Number
    MW5154298
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Report Date
    April 22, 2024
    Manufacturer
    ARXIUM INC.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SOFTWARE FOR MEDSELECT MEDICATION CABINET SYSTEM IS ERRONEOUSLY TRACKING/CHANGING COUNTS IN ITS INTERNAL LOG INCLUDING FOR CONTROLLED SUBSTANCES. THIS IS CAUSING DISCREPANT INFORMATION FOR CONTROLLED SUBSTANCE TRACKING WHEN THE COUNT BY STAFF IS CORRECT. THIS IS REQUIRING EXTENDING TIME FROM STAFF TO CLARIFY, REVIEW AND DECIPHER COUNTS OF CONTROLLED SUBSTANCES. THIS HAS BEEN REPORTED TO ARXIUM WITH NO UPDATES FOR FIXES FOR OVER A YEAR. MOST RECENT EVENT (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879235 MEDSELECT ADS SYSTEM SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP ARXIUM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown