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

Model Number MMT-105NNPKNA

Device Problems Break (1069); Moisture or Humidity Problem (2986); Wireless Communication Problem (3283)

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

Event Date 08/07/2022

Event Type  malfunction  

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.Customer reports: exposed to water and no longer pairs to phone.Per visual inspection: no physical damage to cap, cartridge holder, or inpen was noted.Several attempts were made to pair inpen, every time app displayed dose doesn't match.The inpen does not pair with commercial mobile app.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.Inpen dose button was removed and electronic stack, flex connector and battery were inspected for electrical faults, moisture damage, workmanship and cracked or damage components.The electronic were found corroded.In conclusion: it was determined inpen failed pairing due to ingress of water corroding and causing electrical shorting at the electronic assembly.The customer complaint of not transmitting doses/pairing was confirme 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 insulin pen was exposed to wetness and no longer could be paired with the phone.No harm requiring medical intervention was reported.The insulin pen was returned for analysis.

• 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: 15925151
• MDR Text Key: 308002574
• Report Number: 3012822846-2022-01698
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000368
• UDI-Public: (01)000010862088000368(17)230427
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2023
• Device Model Number: MMT-105NNPKNA
• Device Catalogue Number: MMT-105NNPKNA
• Device Lot Number: B0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Date Manufacturer Received: 08/10/2022
• 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: 16 YR
• Patient Sex: Female
• Patient Weight: 57 KG