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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 Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/06/2022
Event Type  malfunction  
Event Description
Information received by medtronic indicated that the inpen was broken and damaged.Customer stated that the inpen was not working and was not dispensing the insulin.No harm requiring medical intervention was reported.Troubleshooting was performed, the customer will discontinue the use of device.
 
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.
 
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Brand Name
DEMO KIT DEMMT-105ELNA INPEN ELI LILY
Type of Device
SYRINGE, 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 Key13709521
MDR Text Key289427371
Report Number3012822846-2022-00216
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 Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDEMMT-105ELNA
Device Catalogue NumberDEMMT-105ELNA
Was Device Available for Evaluation? No
Date Manufacturer Received03/06/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age44 YR
Patient SexFemale
Patient Weight105
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