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

Model Number MMT-105NNBLNA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970); Vomiting (2144)

Event Date 11/15/2021

Event Type  Injury  

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

The customer reported via phone call that they were experiencing high blood glucose.Blood glucose level at the time of the incident was 400 mg/dl.The customer's current blood glucose level was 260 mg/dl.Customer stated that the insulin inpen was not dispensing the full dose.Customer was treated with manual injection for high blood glucose.Customer also reported that the inpen was broken.Customer also reported nausea, vomiting, abdominal pain due to high blood glucose.The insulin inpen will be returned for analysis.Frn-unk-rsvr, unomed set.

Manufacturer Narrative

Serial number:(b)(6).Software version: 3.8.5.Color: blue.Battery life remaining: 11 months.Customer reports: the dose button won't go past 0.1.Even if i want 4.0 units it won't do it.I used it before and it worked, but now it doesn't.Per visual inspection: no physical damage to inpen noted.The inpen paired with commercial mobile app with a 2.0u dose.The inpen screw retracts when dialing and advances when turning dose knob and high resistance while dispensing and dialing noted.High resistance dialing and dosing after 3.0 units.The dose button was removed and no dust / debris under the dose button or dose knob noted.Inpen was cut open and after inspection it was 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.Also contamination build up found caused by encoder wheel tabs rubbing at the walls of the dose nut.In conclusion: it was determined complaint of hard to turn the inpen, hard to dial, hard to push to give insulin was confirmed due to encoder pattern wheel rotating and traveling against the walls of the dose nut.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-105NNBLNA NOVO NORDISK 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: 12909062
• MDR Text Key: 281515612
• Report Number: 3012822846-2021-00842
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000344
• UDI-Public: (01)000010862088000344(17)230507
• 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
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/07/2023
• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Device Lot Number: B0128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/20/2021
• 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: 57 YR
• Patient Weight: 181 KG