MAUDE Adverse Event Report: ARXIUM INC. MEDSELECT ADS SYSTEM; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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.

• Brand Name: MEDSELECT ADS SYSTEM
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): ARXIUM INC.
• MDR Report Key: 19183687
• MDR Text Key: 341188176
• Report Number: MW5154298
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Patient Sequence Number: 1