MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105ELGYNA ELI LILY GRAY; SYRINGE, PISTON

Model Number MMT-105ELGYNA

Device Problems Computer Software Problem (1112); Material Too Rigid or Stiff (1544)

Patient Problem Hyperglycemia (1905)

Event Date 04/03/2023

Event Type  Injury  

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Serial number: (b)(4).Software version: 3.9.0.Color: grey.Battery life remaining: <9 months.First bond date: jan.4, 2023, initial battery %: 86.Last bond date: apr.5, 2023, last battery %: 85.User mobile device: iphone 13.Ios: 16.4.Testing mobile device: iphone 12.Ios: 16.3.1.Customer reports: the inpen will not dispense any insulin, dose knob/dial difficult to turn and dose log inaccuracy.Per visual inspection: no physical damage noted to cartridge holder and inpen front and back shell.Inpen paired to the commercial app.Inpen received with leadscrew 1/4 of travel.Performed bayonet bond investigation and found leadscrew and cartridge stop rotating together when dispensing due to broken bayonet bond.Unable to perform functional testing due to broken bayonet bond.In conclusion: during investigation dose knob/dial did not demonstrate difficult to turn.Unable to verify customer concern of dose log inaccuracy due to broken bayonet bond.Broken bayonet bond can affect insulin delivery.However, leadscrew anomaly was confirmed.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.

Event Description

Information received by medtronic indicated that customer reported that inpen was not dispensing insulin.The blood glucose at the time of event was 400 mg/dl.Troubleshooting was performed and found that there were no leaks or moisture.No harm requiring medical intervention was reported.The customer will discontinue will using the device and inpen will be returned for analysis.

• Brand Name: INPEN MMT-105ELGYNA ELI LILY GRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• Manufacturer (Section G): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• Manufacturer Contact: justin ellis ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635265677
• MDR Report Key: 16805540
• MDR Text Key: 313906394
• Report Number: 3012822846-2023-00894
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(17)240913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B1415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 82 KG