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

Model Number MMT-105ELBLNA

Device Problems Break (1069); Material Too Rigid or Stiff (1544)

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

Event Date 02/02/2023

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.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

Information received by medtronic indicated that the customer reported the dose button was stiff and it was hard to press.Troubleshooting was performed and the customer reported that the dose knob/dial was difficult to turn.The intended dose amount was 6 units above. it was also found that the intended dose amount and dose amount recorded in the inpen app was different. no harm requiring medical intervention was reported.The customer will discontinue the use of the inpen.The inpen will be returned for analysis.

Manufacturer Narrative

Customer report: dose dial is difficult to turn/dial and doses not being recorded.Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Inpen did not pair with commercial mobile app or transmit to manufacturing app.Received inpen 1/2 of travel.Re-wound pen.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.Excessive plastic shavings contamination builds up found caused by encoder wheel tabs rubbing at the walls of the dose nut.Abrasions down the length of the dose nut.Unable to perform functional test due to difficult to dial/dose.Performed battery investigation and battery measured 3.04 v.No battery anomaly was noted.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.However, unable to verify dose not logging to app due to difficult to dial/dose anomaly.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: justin ellis ; 1223 world trade drive, 100; san diego, CA 92128 ; 7635265677
• MDR Report Key: 16821304
• MDR Text Key: 314078530
• Report Number: 3012822846-2023-00908
• Device Sequence Number: 1
• Product Code: FMF
• 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: 05/31/2023

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 Model Number: MMT-105ELBLNA
• Device Catalogue Number: MMT-105ELBLNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/31/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 68 KG