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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 10/01/2021
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
Information received by medtronic indicated that the insulin pen had screw movement issue.Customer stated that screw was not moving.Customer assisted with troubleshooting and customer stated that issue was not resolved.No harm requiring medical intervention was reported.The device will not be returned for analysis.
 
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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 Key12575274
MDR Text Key276122094
Report Number3012822846-2021-00777
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 Other
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-105NNBLNA
Device Catalogue NumberMMT-105NNBLNA
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/01/2021
Initial Date FDA Received10/05/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age49 YR
Patient Weight113
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