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

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

Event Date 07/20/2023

Event Type  Other  

Event Description

Omnicell device product selection opening wrong pocket.Order was for ibuprofen 400 mg in omnicell drawer 10, bin 10, order was verified by pharmacy which should have directed the nurse to the correct pocket.When nurse went to the omnicell and selected the order, it opened the azithromycin 250 mg pocket.Nurse identified wrong drug and did an inventory count on both pockets.Identified that both pockets and the correct medication loaded.When the nurse selected the ibuprofen order again, the omnicell directed her again to the azithromycin 250 mg pocket at which time she contacted the pharmacist.The pharmacist advised them to power off the omnicell device and to power back on.Once that occurred, the nurse was directed to again try to remove the ibuprofen by selecting the ibuprofen product and this time it opened the correct ibuprofen 400 mg pocket.Device is opening drawer 10 bin 8 for both azithromycin 250 mg and ibuprofen 400 mg.(b)(6).

• Brand Name: OMNICELL
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): OMNICELL, INC.
• MDR Report Key: 17389917
• MDR Text Key: 319840703
• Report Number: MW5120001
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AZITHROMYCIN; IBUPROFEN
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White