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

Model Number MMT-105ELGYNA

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Polydipsia (2604)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the insulin pen was not working.Customer stated that at the insulin did not exit.Customer stated that the they had high blood glucose and symptoms of excessive thirst.No harm requiring medical intervention was reported.Insulin pen was returned for analysis.

Manufacturer Narrative

(b)(4).Battery life remaining: <11 months, customer reports: the insulin has not been coming out the way it should for 3 or 4 days.I tried to put in insulin and kept going high because no insulin was going in.I depress 5 units for example, and i hear it turning but nothing comes out.Per visual inspection: no physical damage noted.The in pen paired to the commercial app with small pairing dose.The screw is not bent.The leadscrew advances properly when dosing, however, retracts when dialing doses due to heavy dust / debris under the dose button, on washer, on the dose detent and dose knob.Unable to perform functional test due to screw anomaly.In conclusion: in pen leadscrew retracts when dialing, this will can affect the delivery of insulin.The customer complaint of no delivery of insulin was confirmed due to leadscrew anomaly.

• 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: tricha miles ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635140379
• MDR Report Key: 13071974
• MDR Text Key: 282701336
• Report Number: 3012822846-2021-00891
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(17)230408
• 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
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2023
• Device Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Date Manufacturer Received: 12/18/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 96 KG