MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105ELPKNA ELI LILY PINK; SYRINGE, PISTON

Model Number MMT-105ELPKNA

Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the inpen had lead screw anomaly.The customer was reporting that she had put in a new cartridge and she primed the cartridge and nothing came out.She had tried a second time, she primed it 7 times before the insulin came out and she gave herself 15 units and at dinner time she primed and the insulin had not come out and she had to prime 7 more times.Customer had reported screw was not moving as intended.Customer stated that injection foot touching the plunger inside the cartridge.It was also reported that screw does not move when dose button was pushed.No harm requiring medical intervention was reported.The inpen will be returned for analysis.

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Information received by medtronic indicated that the inpen had lead screw anomaly.The customer was reporting that she had put in a new cartridge and she primed the cartridge and nothing came out.She had tried a second time, she primed it 7 times before the insulin came out and she gave herself 15 units and at dinner time she primed and the insulin had not come out and she had to prime 7 more times.Customer had reported screw was not moving as intended.Customer stated that injection foot touching the plunger inside the cartridge.It was also reported that screw does not move when dose button was pushed.No harm requiring medical intervention was reported.The inpen will be returned for analysis.

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

• Brand Name: INPEN MMT-105ELPKNA ELI LILY PINK
• 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: 13170723
• MDR Text Key: 285536583
• Report Number: 3012822846-2022-00012
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000010862088000337
• UDI-Public: (01)000010862088000337(17)220629
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2022
• Device Model Number: MMT-105ELPKNA
• Device Catalogue Number: MMT-105ELPKNA
• Device Lot Number: B93KB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 67 YR
• Patient Weight: 192