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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 Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 10/17/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer reports: in pen end part of pen popped out. It's the part where he presses the button. Per visual inspection: in pen received with detached electronic housing, broken off flex pcba. During complaint investigation: the electronic housing assembly, dose button popped out and it was noted that the flex connector was cut open from encoder contact board. Unable to perform any test due to physical damage. In conclusion: the customer complaint of dose button and electronic housing assembly popped out is confirmed.
 
Event Description
Information received by medtronic indicated that the insulin pen end part popped out when tried cap off with button came off. No harm requiring medical intervention was reported. The insulin pen will be returned for analysis.
 
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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 Key12876565
MDR Text Key282547708
Report Number3012822846-2021-00837
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 Other
Reporter Occupation
Type of Report Initial
Report Date 11/25/2021
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
Device Lot NumberB94MV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2021
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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