MAUDE Adverse Event Report: MEDTRONIC MINIMED INPEN

Model Number MMT-XXX

Device Problems Computer Software Problem (1112); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.This mdr is related to the retrospective review of complaints from companion medical inc, following medtronic¿s acquisition of the company in september 2020.

Event Description

Participant for clinical study reported there was an inaccuracy between the dose intended and dose recorded.The participant stated the logbook recorded large doses they did not administer.Customer¿s blood glucose was unknown.No harm requiring medical intervention was reported.The insulin pen will not be returned for analysis.

Manufacturer Narrative

Five total pens were sent back for investigation.Two of them did not broadcast to the manufacturing app, were disassembled, and found to have physical damage.One had cracked flex and no encoder connection, the other had a depleted battery and thin capacitors.One had no functional issues, but did have a broken cartridge holder.The last two were reported to have phantom doses.One of those pens was an older build with thin capacitors.This may have causes multiple re-sets.The last pen had no physical issues, was the current build, but was found to have multiple 30 units doses on 9/25 in the cloud data.All were version 3.8.2 of the firmware.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: INPEN
• Type of Device: INPEN
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 11916643
• MDR Text Key: 256574942
• Report Number: 2032227-2021-151732
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1