MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY; SYRINGE, PISTON

Model Number MMT-105NNGYNA

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported dose knob/dial difficult to turn. no harm requiring medical intervention was reported. troubleshooting was performed.The customer was instructed to discontinue the use of the device.The product will be returned for failure analysis.

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.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.Serial number: (b)(6).Software version: 3.8.5.Color: grey.Battery life remaining: 12 months.First bond date: n/a.Initial battery %: n/a.Last bond date: n/a.Last battery %: n/a user mobile device: n/a.Testing mobile device: iphone 12.Ios: 16.3.1.Customer report: dose dial is difficult to turn/dial.Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Inpen paired with commercial mobile app with small dose.Received inpen fully extended of travel.Performed encoder bond investigation and found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Abrasions down the length of the dose nut.Unable to perform functional test due to difficult to dial/dose.In conclusion: it was determined from destructive analysis that the difficult to dial/dose was caused by a pattern wheel misalignment due to an encoder base bond failure.This can affect insulin delivery.Therefore, the customer concern of dose dial being difficult to dial/dose was 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.

Manufacturer Narrative

Inpen paired with commercial mobile app with small dose.Received inpen fully extended of travel.Performed encoder bond investigation and found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Abrasions down the length of the dose nut.Unable to perform functional test due to difficult to dial/dose.In conclusion: it was determined from destructive analysis that the difficult to dial/dose was caused by a pattern wheel misalignment due to an encoder base bond failure.This can affect insulin delivery.Therefore, the customer concern of dose dial being difficult to dial/dose was 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-105NNGYNA NOVO NORDISK GRAY
• 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: justin ellis ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635265677
• MDR Report Key: 16805701
• MDR Text Key: 313905952
• Report Number: 3012822846-2023-00896
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 0000108620880003
• UDI-Public: (01)0000108620880003(17)230907(10)B0600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201337
• 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
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2023
• Device Model Number: MMT-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B0600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Date Manufacturer Received: 04/25/2023
• 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: A
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 73 KG