MAUDE Adverse Event Report: OMNICELL, INC. OMNICELL; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problems Date/Time-Related Software Problem (2582); Inadequate User Interface (2958)

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

Event Type  Other  

Event Description

Our institution recently changed our adcs(antibody-drug conjugates) to omnicell.Since the switch, we have noticed multiple issues with expiration date data entry errors on the part of our technicians and nursing staff.A major issue is that omnicell allows for any date to be entered into the expiration date field on their machines.This means past dates can be entered.We've reached out to the team at omnicell.Here is a summary of the asked question and the response from omnicell support: question: is there a way for omnicell to stop transaction from being completed when the wrong year (date in the past example: x/xx/2001) is entered? note: when the wrong day of the month (example: xx/xx/2024) is entered, omnicell will not allow transaction to be completed.Answer: there is not a way for the transaction to be stopped if an invalid expiration date was input such as one that expired years ago., that's also a programming / hard-coded thing.Putting in an invalid expiration date just falls under a workflow issue for the cabinet.The cabinet is primarily a listener that takes in the data given to it, right or wrong.I could submit this kind of request as a feature request for future versions of the software, sure.But such capabilities do not exist presently.We have counseled staff on the differences between pyxis and omnicell in regards to the exp dates; we have disallowed returns for nursing staff to isolate dating to pharmacy personnel as much as possible; we have reached out to omnicell support to ask for software updates to fix this issue.(b)(6).Submission id: (b)(4).

• Brand Name: OMNICELL
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): OMNICELL, INC.
• MDR Report Key: 17011164
• MDR Text Key: 316115071
• Report Number: MW5117923
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1