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

Model Number MMT-105NNPKNA

Device Problems Break (1069); Failure to Align (2522); Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the insulin pen screw was not moving as intended, customer also stated that cap was no longer stay attached dosing window was broke off lead screw was rewinding on its own.Customer blood glucose was high and low and declined for trouble shooting.No harm requiring medical intervention was reported.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: pink.Battery life remaining: <4 months.Customer reports: broken dosing window, screw not moving as intended, the injection foot is not touching.Cap does not fit securely to inpen.Per visual inspection: cap does not fit securely to inpen and broken dosing window.Unit paired successfully to commercial app.Inpen received with leadscrew at the end 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 customer complaint of leadscrew anomaly could not be confirmed.However, inpen cap does not fit securely onto cartridge holder due to small snap cracked / broken.The customer complaint of cap no longer staying attached and broken dosing window is 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-105NNPKNA NOVO NORDISK PINK
• 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: 13190496
• MDR Text Key: 283588698
• Report Number: 3012822846-2022-00025
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000368
• UDI-Public: (01)000010862088000368(17)230217
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2023
• Device Model Number: MMT-105NNPKNA
• Device Catalogue Number: MMT-105NNPKNA
• Device Lot Number: B94UB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2022
• 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: 51 YR
• Patient Weight: 81 KG