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

Model Number MMT-105ELPKNA

Device Problems Computer Software Problem (1112); Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 01/31/2023

Event Type  Injury  

Event Description

Information received by medtronic indicated that the customer received the over-delivery alarm.It is also reported hypoglycemia 47 mg/dl and the dose amount of the last insulin delivery was 5.5u.Troubleshooting was performed at the time of the event.No harm requiring medical intervention was reported.The customer will discontinue the use of the device and will be returned for analysis.

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.

Manufacturer Narrative

Serial number: (b)(6).Software version: 3.8.5.Color: pink.Battery life remaining: <6 months.Mobile device: n/a.First bond date: aug.1, 2022 initial battery %: 100.Last bond date: feb.10, 2023 last battery %: 80.Customer reports: dose log inaccuracy, inpen is not dispensing insulin and alleged low bgs.Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.The inpen paired to the commercial app.Inpen failed baseline and wireless functionality.App logbook displayed: 14.5u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u.Installed front shell to testing inpen and front shell did stay attached.Pending further investigation performed in san diego location.In conclusion: per san diego analysis: inpen passed base line functionality test but failed displacement dose accuracy.Clutch skips on larger doses due to clutch wear.This can affect insulin delivery.Therefore, the customer concern of dose log inaccuracy was confirmed.However, unable to verify possible over delivery anomaly due to dose log inaccuracy.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.

Manufacturer Narrative

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.Information has been added which was not included in the initial report.The information has been provided in section h6 (health effect - clinical code, health effect - impact code) with this report.

• 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: tricha miles ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635140379
• MDR Report Key: 16441490
• MDR Text Key: 310227700
• Report Number: 3012822846-2023-00625
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000337
• UDI-Public: (01)000010862088000337(17)240629
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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: B1236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Date Manufacturer Received: 05/16/2023
• 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 Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 70 KG