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

Model Number MMT-105NNGYNA

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2021

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.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.

Event Description

Information received by medtronic indicated that the insulin pen had a leadscrew anomaly.Customer¿s blood glucose was unknown.No harm requiring medical intervention was reported.The insulin pen will be returned for analysis.

Manufacturer Narrative

Serial number: (b)(6).Software version: 3.8.5 color: grey battery life remaining: <11 months customer reports: unable to turn his pen past 4.5, states it starts to stick.Per visual inspection: no physical damage the inpen paired to the commercial app with small pairing dose.The screw is not bent.The leadscrew advances properly when dosing less that 3.0 unit, however, when dialing more than 4.0 units the leadscrew retracts and a high resistance its feel at the dial.Unable to perform functional test due to leadscrew anomaly.In conclusion: the customer complaint of unable to dial more than 4.5 units and leadscrew anomaly was confirmed.Pending further analysis that will be perform in san diego location.Per (b)(6), destructive testing showed that leadscrew anomaly was caused by a pattern wheel misalignment due to an encoder base bond failure.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-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: tricha miles ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635140379
• MDR Report Key: 13102114
• MDR Text Key: 285222935
• Report Number: 3012822846-2021-00915
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000351
• UDI-Public: (01)000010862088000351(17)230521
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/21/2023
• Device Model Number: MMT-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR