MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN

Model Number MMT-XXX

Device Problems Material Separation (1562); Failure to Deliver (2338); Unintended Movement (3026)

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

Event Date 01/26/2021

Event Type  malfunction  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they were having issue with the insulin pen.Customer stated the plunger seems to backdrive during some larger doses and unseats the plunger tip from the rubber stopper.The customer had been dosing but realized insulin wasn't being delivered.No harm requiring medical intervention was reported.It is unknown if the insulin pen will be return for analysis.

• Brand Name: INPEN
• Type of Device: INPEN
• 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: neal grant ; 1223 world trade drive, 100; san diego, CA 92128
• MDR Report Key: 11254187
• MDR Text Key: 230522337
• Report Number: 3012822846-2021-00023
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Device Lot Number: B93FL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• 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 Age: 33 YR