• 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-105ELGYNA ELI LILY 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-105ELGYNA ELI LILY GRAY SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELGYNA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 10/17/2020
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. 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
The customer's mother reported via phone call that the customer experienced high blood glucose. The blood glucose reading was 500 mg/dl. The customer treated their high blood glucose with manual injection. No harm requiring medical intervention was reported. The insulin pen will not be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINPEN MMT-105ELGYNA ELI LILY 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 Key11886939
MDR Text Key255930448
Report Number3012822846-2021-00279
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
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-105ELGYNA
Device Catalogue NumberMMT-105ELGYNA
Device Lot NumberB92EH
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
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

-
-