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

Model Number MMT-105NNBLNA

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Serial number: (b)(4), software version: 3.8.5, color: blue , battery life remaining: <6 months.Customer reports: was trying to replace his insulin cartridge in the pen and broke the device.Per visual inspection: no cosmetic damage was noted.The inpen paired to the commercial app with small pairing dose.The screw is not bent.Leadscrew was received fully extended.Leadscrew was rewound.However, advances when turning dose knob to the 0 mark and high resistance while dispensing.Inpen dose button was removed and no lint or dust bunnies were found under dose button.Inpen was cut open and after inspection it was found that the encoder pattern wheel tabs rotating causing misalignment of the encoder 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.In conclusion: a leadscrew anomaly was found during testing.The customer complaint of cosmetic / physical damage could not be confirmed.

Event Description

Information received by medtronic indicated that the insulin cartridge in the pen was broke.No harm requiring medical intervention was reported.The inpen will be returned for analysis.

• 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: 13101866
• MDR Text Key: 285222604
• Report Number: 3012822846-2021-00911
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 0000108620880003
• UDI-Public: (01)0000108620880003(17)230412(10)B0031
• 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
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2023
• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Device Lot Number: B0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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 Weight: 295