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

Model Number MMT-105NNBLNA

Device Problem Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Serial number: n/a, software version: n/a, color: blue , battery life remaining: n/a.The inpen screw retracts when dialing and advances when turning dose knob to the 0 mark due to dust/debris under the dose button, on washer and on the dose detent.Unable to perform functional test due to leadscrew anomaly.The dose indicator mark and printed values on the dose knob are with a free play of 0.5 due to misalignment of the dial assembly.Inpen cap does not fit securely onto cartridge holder due to small snap cracked / broken.Test cap snaps securely to the returned cartridge holder.

Event Description

The customer reported via phone all that their insulin pen was broken and had dose slippage.Customer's blood glucose was 220 mg/dl.No harm requiring medical intervention was reported.The insulin pen 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: 11971381
• MDR Text Key: 258622215
• Report Number: 3012822846-2021-00506
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-105NNBLNA
• Device Catalogue Number: MMT-105NNBLNA
• Device Lot Number: B93UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Date Manufacturer Received: 06/08/2021
• 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: 21 YR
• Patient Weight: 130