MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY; SYRINGE, PISTON

Model Number MMT-105NNGYNA

Device Problems Break (1069); Connection Problem (2900)

Patient Problem Hyperglycemia (1905)

Event Date 04/07/2023

Event Type  Injury  

Manufacturer Narrative

Per visual inspection: broken off piece at the cartridge holder.No physical damage to inpen front or back shell.Unit paired successfully to commercial app.Inpen received with leadscrew 1/4 of travel.Cartridge holder broken off plastic pieces stuck inside inpen/cartridge holder cavity.Inpen passed front cap investigation.In conclusion: inpen received with broken off piece at the cartridge holder and did not lock in place due to broken off piece being stuck inside inpen/cartridge holder cavity.Physically damaged cartridge holders can affect insulin delivery.Therefore, the customer concern of cartridge holder not locking in place 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 the customer experienced hyperglycemia with a blood glucose value of 400 mg/dl at the time of the event and also reported inpen cartridge holder was not turning to lock in place.It was also reported that the customer did not get insulin from the pen and noticed chemical like alcohol smell.The hyperglycemia was treated with insulin manual injection.The customer stated no symptoms troubleshooting was performed and found that the customer was using inpen application dose calculator.It was found that the insulin didn't exit during dispensing a 2 units prime in the air.No further patient complications were reported.The customer will discontinue the use of the inpen.The inpen was returned for analysis.

• Brand Name: INPEN MMT-105NNGYNA NOVO NORDISK 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: 16813304
• MDR Text Key: 313987495
• Report Number: 3012822846-2023-00901
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000351
• UDI-Public: (01)000010862088000351(17)240613
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B1203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR
• Patient Weight: 127 KG