• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNGYNA
Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Unintended Movement (3026)
Patient Problem Hypoglycemia (1912)
Event Date 03/09/2021
Event Type  Injury  
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
The customer's mother reported via phone call that the dial marker was loose and does not align with the numbers which may have led to few units or too many units of insulin delivered and resulted low blood glucose of 44 mg/dl. No medical intervention was reported. The insulin pen is expected to return for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11467572
MDR Text Key242694075
Report Number3012822846-2021-00062
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,other
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-105NNGYNA
Device Catalogue NumberMMT-105NNGYNA
Device Lot NumberB92WA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
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

-
-