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

Model Number MMT-105ELPKNA

Device Problems Break (1069); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the insulin pen dose dial misaligned was greater than 1 unit.Dose button popped off.Customer was trying to deliver a 30 unit dose when the dose button popped off.No harm requiring medical intervention was reported.The customer will discontinue to use the device.

Manufacturer Narrative

Per visual inspection: electronic housing detached from dose knob, flex electrical board a detached from encoder base.The alignment of the dose indicator mark and printed values on the dose knob is nominal.No misalignment of the dial was noted.Inpen received physically damaged.Inpen leadscrew was received 1/4 of travel, re-wound leadscrew.Unable to perform functional test due to inpen being physical damage.In conclusion: inpen received with the entire electronic housing sliding out of the dose knob due to broken off solder joints.Therefore, customer complaint of inpen being physically damaged at the dose button was confirmed.However, the customer complaint of dose dial being 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-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: 14941445
• MDR Text Key: 302059926
• Report Number: 3012822846-2022-00923
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000337
• UDI-Public: (01)000010862088000337(17)230429
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2023
• Device Model Number: MMT-105ELPKNA
• Device Catalogue Number: MMT-105ELPKNA
• Device Lot Number: B0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Date Manufacturer Received: 06/17/2022
• 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: 69 YR
• Patient Weight: 83 KG