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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON

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COMPANION MEDICAL INC INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELBLNA
Device Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 12/25/2021
Event Type  Injury  
Event Description
Customer reported via phone call that they had experienced high blood glucose levels. Blood glucose level at the time of incident was 500 mg/dl. Customer reported the dose log was not showing the full amount. The intended dose amount and dose amount recorded in the inpen app was greater than 1. 0 unit. The inpen will be returned for analysis.
 
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. Further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
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Brand NameINPEN MMT-105ELBLNA ELI LILY 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 Key13472984
MDR Text Key285183189
Report Number3012822846-2022-00092
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000313
UDI-Public(01)000010862088000313(17)230419
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105ELBLNA
Device Catalogue NumberMMT-105ELBLNA
Device Lot NumberB0066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2022
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

Patient Treatment Data
Date Received: 02/07/2022 Patient Sequence Number: 1
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