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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNBLNA
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 11/13/2021
Event Type  malfunction  
Event Description
The information received by medtronic indicated that the insulin pen was not dispensing insulin. They stated that insulin pen will get stuck and not deliver the entire intended amount, it went 1,2,3 and quit. They the removed the cartridge holder and turned the dial to 5 units, when pressing the button to dispense, insulin pen will only move the dial down to 2 units and not 0 like it should, stated they had to press very hard to move it. He tried 30 units and insulin pen only let him push it to 6 units. No harm requiring medical intervention was reported. The insulin pen 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.
 
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Brand NameINPEN MMT-105NNBLNA NOVO NORDISK BLUE
Type of DeviceSYRINGE, 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 Key12879691
MDR Text Key282553806
Report Number3012822846-2021-00841
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNBLNA
Device Catalogue NumberMMT-105NNBLNA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/16/2021
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 Unkown

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