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

Model Number MMT-105NNGYNA

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the insulin pen had a lead screw anomaly.Customer stated that the screw is not moving as intended.Customer¿s blood glucose was unknown.No harm requiring medical intervention was reported.Customer will discontinue use of the device.

Manufacturer Narrative

Serial number: (b)(4); software version: 3.8.3; color: grey; battery life remaining: < 12 months; per visual inspection: no physical damage to cap, cartridge holder or inpen was noted.Customer reports: leadscrew is not moving as intended.Unit paired successfully to commercial app.Inpen received with leadscrew fully re-winded.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 not moving as intended was not confirmed.

• Brand Name: INPEN MMT-105NNGYNA NOVO NORDISK GRAY
• 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: 13691891
• MDR Text Key: 289324340
• Report Number: 3012822846-2022-00203
• Device Sequence Number: 1
• Product Code: FMF
• 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: 03/07/2022

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-105NNGYNA
• Device Catalogue Number: MMT-105NNGYNA
• Device Lot Number: B92JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/08/2022
• 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: 12 YR
• Patient Weight: 110