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

Model Number MMT-105ELBLNA

Device Problems Computer Software Problem (1112); Wireless Communication Problem (3283)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Information received by medtronic indicated that the insulin pen app was not recording the exact doses dialed on the insulin pen.Customer removed the cartridge holder and then dispense 5 units three times.Customer stated the 5.0 units did not recorded in the logbook each time.No harm requiring medical intervention was reported.The insulin pen will be returned for analysis.

Manufacturer Narrative

Serial number: software version: color: blue.Battery life remaining: per visual inspection: no physical damage to inpen.Customer reports: inpen having trouble connecting it to inpen app.Doses are not recorded in the logbook.Several attempts were made to pair inpen, every time app displayed dose doesn't match.The inpen does not pair with commercial mobile app.The screw was not bent, advanced when dosage knob was pressed dialing a dosage and retracted appropriately.No resistance was observed when dosing without a cartridge installed.The screw advanced every time 30.0u was dialed and dosed until the screw reached max extension.Inpen dose button was removed and electronic stack, flex connector and battery were inspected for electrical faults, moisture damage, workmanship and cracked or damage components.The electronic assembly was found with traces of corrosion.A battery test was performed and battery at 0.76 volts.It was determined the pairing / no communication anomaly was caused by the ingress of fluids corroding the electronic assembly.Unable to verify customer complaint of logging of inaccurate doses in the inpen commercial app due to moisture damage.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: 13341142
• MDR Text Key: 286639149
• Report Number: 3012822846-2022-00051
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000313
• UDI-Public: (01)000010862088000313(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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

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: 04/29/2023
• Device Model Number: MMT-105ELBLNA
• Device Catalogue Number: MMT-105ELBLNA
• Device Lot Number: B0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/22/2022
• 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: 81 YR
• Patient Sex: Male