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

Model Number MMT-105ELGYNA

Device Problems Computer Software Problem (1112); Material Too Rigid or Stiff (1544); Appropriate Term/Code Not Available (3191)

Patient Problems Hyperglycemia (1905); Urinary Frequency (2275); Polydipsia (2604)

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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

The customer experienced hyperglycemia with a blood glucose value of 400 mg/dl at the time of the event and was treated with a manual injection/insulin pen for the high blood glucose.The customer was reported thirsty, and urinating as symptoms reported related to their high blood glucose.The customer reported an inaccuracy dose log of the inpen and the dose knob was difficult to turn.The troubleshooting was performed and found that the intended dose amount and dose amount recorded in the inpen app (logbook or home screen) was greater than 1.0 units.No further patient complications were reported.The customer will discontinue the use of the device and will be returned for analysis.

Manufacturer Narrative

Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Cartridge holder locks properly in place.Inpen paired to the commercial app.Retracting leadscrew was noted when dialing.Performed dust/debris investigation and found visible horizontal abrasions on the outside of electronics housing.This indicated debris was lodged between the dose knob and electronics housing causing the leadscrew anomaly.Unable to perform baseline/wireless functionality and displacement dose accuracy test.Performed leadscrew reset torque test.Inpen within specification (cw: 0.35 ozf-in and ccw: 4.35 ozf-in).Inpen passed front cap investigation.In conclusion: deconstructive analysis demonstrated visible horizontal abrasions on the electronics housing were noted.This indicated debris was lodged between the knob and electronics housing causing the leadscrew to retract.This can affect insulin delivery.Therefore, leadscrew anomaly was confirmed.Difficult to dial/dose was not confirmed.Unable to confirm dose log inaccuracy due to leadscrew anomaly.Unable to confirm high bg.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
• Manufacturer (Section G): COMPANION MEDICAL INC; 1223 world trade drive, 100; san diego CA 92128
• Manufacturer Contact: lusine boyadzhyan ; 1223 world trade drive, 100; san diego, CA 92128
• MDR Report Key: 17843317
• MDR Text Key: 324583281
• Report Number: 3012822846-2023-01639
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000320
• UDI-Public: (01)000010862088000320(17)231208
• 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,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2023
• Device Model Number: MMT-105ELGYNA
• Device Catalogue Number: MMT-105ELGYNA
• Device Lot Number: B0921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 79 KG