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

Model Number MMT-105NNGYNA

Device Problem Unintended Movement (3026)

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

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

Unit paired successfully to commercial mobile app.Inpen high resistance was felt upon dispensing without a cartridge due to dust/debris under dose button, on washer and dose detent.My inpen menu displayed: the following test values were dialed and dosed: 4.0u, 4.0u, 4.0u, 4.0u this values displayed accurately in the logbook.However, two 16 units values were dialed and 12.0 u and 9.5 u were recorded.The inpen values of 16 units transmitted did not matched bolus dialed, problem was isolated to the high resistance cause by dust/debris under dose button, on washer and dose detent.Inpen received with missing dose window.The alignment of the dose indicator mark and printed values on the dose knob is nominal.No misalignment of the dial was noted.

Event Description

The customer's family member reported via phone call that the insulin pen dose knob is misaligned with the dose mark indicator.Customer¿s blood glucose was unknown.No harm requiring medical intervention was reported.The insulin pen was returned for analysis.

• 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: 11940799
• MDR Text Key: 258016347
• Report Number: 3012822846-2021-00500
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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: B93EP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 06/04/2021
• 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 Age: 12 YR