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

Model Number MMT-105ELBLNA

Device Problems Insufficient Flow or Under Infusion (2182); Connection Problem (2900); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the inpen was not delivering.Customer stated screw was not moving as intended.Customer stated that no insulin was dispensed when the button was pushed.Customer stated that no insulin exist with initial prime.Customer reported that does dial was misaligned.No harm requiring medical intervention was reported.The customer will discontinue use of the device.

Manufacturer Narrative

Customer reports: leadscrew is not moving as intended, dose dial is misaligned and cartridge holder is broken.Per visual inspection: no physical damage to cap, cartridge holder or inpen was noted.The alignment of the dose indicator mark and printed values on the dose knob is nominal.No misalignment of the dial was noted.The inpen paired to the commercial app with small pairing dose.Received inpen 1/4 of travel.Unable to re-wind inpen.The leadscrew does unexpectedly retracts into the inpen while dialing doses.Unable to perform functional test due to leadscrew retracting anomaly.Pending further analysis that will be performed at san diego location.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

Per visual inspection: no physical damage to cap, cartridge holder or inpen was noted.The alignment of the dose indicator mark and printed values on the dose knob is nominal.No misalignment of the dial was noted.The inpen paired to the commercial app with small pairing dose.Received inpen 1/4 of travel.Unable to re-wind inpen.The leadscrew does unexpectedly retracts into the inpen while dialing doses.Unable to perform functional test due to leadscrew retracting anomaly.In conclusion: per dennis berg san diego investigation: leadscrew anomaly was caused by debris was lodged between the dose dial and the electronics housing causing it to retract and extend when dialing a dose.Therefore, the customer complaint of leadscrew anomaly was confirmed due to dust/debris.However, no physical damage was noted on cartridge holder and dose dial is not misaligned.Therefore the customers complaint of cartridge holder being broken and dose dial is misaligned was not confirmed.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-105ELBLNA ELI LILY BLUE
• 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: 14796747
• MDR Text Key: 302958572
• Report Number: 3012822846-2022-00884
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 0000108620880003
• UDI-Public: (01)0000108620880003(17)230607(10)B0235
• 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: 07/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/07/2023
• Device Model Number: MMT-105ELBLNA
• Device Catalogue Number: MMT-105ELBLNA
• Device Lot Number: B0235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/04/2022
• 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: 23 YR
• Patient Sex: Male
• Patient Weight: 160 KG