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

Model Number MMT-105ELGYNA

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Hyperglycemia (1905)

Event Date 06/15/2021

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

The customer reported via phone call that they were having issue with the insulin pen screw.Customer primed the insulin pen multiple times and replaced the needles, but the issue was not resolved.Customer stated the screw pulls back into the insulin pen when they dial a dose.Customer¿s blood glucose was 252 mg/dl.No harm requiring medical intervention was reported.The insulin pen will be returned for analysis.

Manufacturer Narrative

Serial number: n/a.Software version: n/a.Color: grey.Battery life remaining: n/a.The inpen screw retracts when dialing and advances when turning dose knob to the 0 mark and high resistance while dispensing due to dust/debris under the dose button, on washer and on the dose detent.Unable to perform functional test due to leadscrew anomaly.No physical damage to injection foot or inpen 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 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
• MDR Report Key: 12009465
• MDR Text Key: 259659829
• Report Number: 3012822846-2021-00522
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(17)230104
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2023
• Device Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B94GY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 220