DISPILL MULTIDOSE SOFTWARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for DISPILL MULTIDOSE SOFTWARE manufactured by .

Event Text Entries

[59819416] This involves an error related to dispill multidose software. The program keeps a manually entered medication profile for each patient who receives the dispill package. When trying to print a dispill card for one patient, then pharmacist erroneously changed the name of the patient, though they thought they were searching for the patient. A different patient's profile had been left up on the screen, which allowed the pharmacist to alter the name. We reached out to dispill to see if there could be an auto-log out put in place, so if a patient was left up for a particular amount of time, the system would log out. We were told that dispill would not do this however. We do have other catches internally in place to make sure that these types of errors don't occur, however the pharmacist did not follow those policies. Medication not administered to or used by the patient. Relevant material not provided. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065954
• MDR Report Key: 6092403
• Date Received: 2016-11-08
• Date of Report: 2016-07-25
• Date Added to Maude: 2016-11-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: DISPILL MULTIDOSE SOFTWARE
• Generic Name: DISPILL MULTIDOSE SOFTWARE
• Product Code: NXB
• Date Received: 2016-11-08
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-11-08