MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN

Model Number MMT-XXX

Device Problem Calibration Problem (2890)

Patient Problem Overdose (1988)

Event Date 02/24/2021

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.

Event Description

The customer reported via phone call that the insulin pen was over delivering insulin due to the dose dial calibration appearing to be a bit off.The customer stated that the misalignment has gotten worse and the customer has been giving themselves too much insulin more and more lately.No harm requiring medical intervention was reported.It is unknown if the insulin pen will be returned for analysis.

Manufacturer Narrative

The injection screw was not bent it advanced/retracted correctly.No resistance was observed when dosing without a cartridge installed.In pen paired successfully to commercial mobile app.The following test values were dialed and dosed: 4.0u, 4.0u, 4.0u, 4.0 and 16.0u.All values displayed accurately in the dose log.No cosmetic damage was observed.No mis-alignment confirmed.The alignment of the dose indicator mark and printed values on the dose knob is nominal.No misalignment of the dial was noted.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): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• MDR Report Key: 11382560
• MDR Text Key: 242693787
• Report Number: 3012822846-2021-00044
• 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: 03/30/2021

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: 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: 03/10/2021
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR