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

Model Number MMT-105ELBLNA

Device Problem Computer Software Problem (1112)

Patient Problem Hypoglycemia (1912)

Event Date 11/18/2021

Event Type  Injury  

Event Description

The customer reported via phone call that they were experienced low blood glucose level.Customer¿s blood glucose level was 48 mg/dl at the time of incident.Customer also reported that insulin pen app did not recorded exact doses dialed on insulin pen.Customer declined troubleshooting for low blood glucose level.The insulin pen will be returned for analysis.

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.

Manufacturer Narrative

Serial number: (b)(6).Software version: 3.8.5.Color: blue.Battery life remaining: <10 months.Customer reports: having a problem with my daughters inpen.She has an inpen she uses at school 3 days ago it says she is supposed to give 7 units and when she primed, when she gives 9 and then it shows 7 and then 2 and she says to stop using it.The dose amount delivered is more than what was dialed in on the inpen.Per visual inspection: no physical / cosmetic damage noted.Unit paired successfully to commercial app.My inpen menu displayed: the following test values were dialed and dosed: 4.0u, 4.0u, 4.0u, 4.0u and 16.0u.All values displayed accurately in the logbook.All doses were written to the app logbook within 1 minute.Inpen received with leadscrew 1/4 of the travel.Re-wound screw.No drag was observed, 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.In conclusion: inpen received working as design.No malfunctions noted during testing that could affect insulin delivery.The patient complaint of dose log inaccuracies could not be confirmed.Pending further analysis that will be perform in 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.

Event Description

It was reported by the customer's family member that the inpen app is not recording the exact doses dialed on the inpen.The dose amount delivered per the logbook is more than what was dialed in on the inpen.

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.The information that provided with the initial report was incorrect.The correct information has been included with this report in b5 section.The information related to event date has been updated and provided in b3 section of this report.

Manufacturer Narrative

Serial number: (b)(6) software version: 3.8.5 color: blue battery life remaining: <10 months customer reports: having a problem with my daughters inpen.She has an inpen she uses at school 3 days ago it says she is supposed to give 7 units and when she primed, when she gives 9 and then it shows 7 and then 2 and she says to stop using it.The dose amount delivered is more than what was dialed in on the inpen.Per visual inspection: no physical / cosmetic damage noted.Device paired successfully to commercial application.My inpen menu displayed: the following test values were dialed and dosed: 4.0 unit, 4.0 unit, 4.0 unit, 4.0 unit and 16.0 unit.All values displayed accurately in the logbook.All doses were written to the app logbook within 1 minute.Inpen received with leadscrew 1/4 of the travel.Re-wound screw.No drag was observed, 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 30.0 unit was dialed and dosed until the screw reached max extension.In conclusion: inpen received working as design.No malfunctions noted during testing that could affect insulin delivery.The patient complaint of dose log inaccuracies could not be confirmed.Pending further analysis that will be perform in san diego location.2/11/2022 per neta glaser, device tested ok and no dose log anomalies were witness in san diego.The customer complaint could not be duplicated.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: 12909471
• MDR Text Key: 281519966
• Report Number: 3012822846-2021-00847
• Device Sequence Number: 1
• Product Code: FMF
• 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,Followup,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105ELBLNA
• Device Catalogue Number: MMT-105ELBLNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• 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 Outcome(s): Other
• Patient Age: 9 YR