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

Model Number MMT-105ELPKNA

Device Problems Break (1069); Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Date 06/19/2023

Event Type  Injury  

Event Description

Information received by medtronic indicated that the customer reported broken cartridge holder of inpen.Customer also reported hyerglycemia with blood glucose value of 420 mg/dl. troubleshooting was performed.No harm requiring medical intervention was reported.The device was returned for failure analysis.

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Per visual inspection: broken off piece at the cartridge holder and inpen front shell does not stay attached.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 failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken.Test inpen was used to perform front cap investigation.In conclusion: inpen received with broken off piece at the cartridge holder.Physically damaged cartridge holders can affect insulin delivery.The customer concern of physical damage at cartridge holder was confirmed.Cap anomaly was confirmed.Cosmetic damage was not 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.

• Brand Name: INPEN MMT-105ELPKNA ELI LILY PINK
• 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: 17341184
• MDR Text Key: 319379379
• Report Number: 3012822846-2023-01301
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000337
• UDI-Public: (01)000010862088000337(17)250124
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105ELPKNA
• Device Catalogue Number: MMT-105ELPKNA
• Device Lot Number: B1626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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: 15 YR
• Patient Sex: Female
• Patient Weight: 59 KG