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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC DEMO KIT DEMMT-105ELNA INPEN ELI LILY SYRINGE, PISTON

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COMPANION MEDICAL INC DEMO KIT DEMMT-105ELNA INPEN ELI LILY SYRINGE, PISTON Back to Search Results
Model Number DEMMT-105ELNA
Device Problem Computer Software Problem (1112)
Patient Problem Insufficient Information (4580)
Event Date 09/22/2021
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 there was an inaccuracy between the dose intended and dose recorded. The dose was greater than 1. 0 unit of insulin. No harm requiring medical intervention was reported. The insulin pen will not be returned for analysis.
 
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Brand NameDEMO KIT DEMMT-105ELNA INPEN ELI LILY
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 Key12524657
MDR Text Key273991155
Report Number3012822846-2021-00740
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 other
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEMMT-105ELNA
Device Catalogue NumberDEMMT-105ELNA
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
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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