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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNGYNA
Device Problem Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Date 02/26/2020
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. This mdr is related to the retrospective review of complaints from companion medical inc, following medtronic¿s acquisition of the company in september 2020.
 
Event Description
Customer reported that the screw has problem rewinding. Customer stated the screw does not rewind all the way back. No harm requiring medical intervention was reported. The insulin pen was not returned for analysis.
 
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Brand NameINPEN MMT-105NNGYNA NOVO NORDISK GRAY
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
neal grant
1223 world trade drive, 100
san diego, CA 92128
MDR Report Key11874205
MDR Text Key256803465
Report Number3012822846-2021-00246
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNGYNA
Device Catalogue NumberMMT-105NNGYNA
Device Lot NumberB92B6
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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