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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105ELPKNA ELI LILY PINK SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELPKNA
Device Problems Computer Software Problem (1112); Priming Problem (4040)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 03/29/2021
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
Customer reported via phone call that the insulin pen is not working as their blood glucose has been running high. Blood glucose was 205 mg/dl at the time of the incident. Customer did a correction but the inpen app did not show any insulin delivered then did another correction and blood sugar was 70 mg/dl and went to as low as 40 mg/dl. Customer treated with chocolate. Troubleshooting was performed and customer was able to change the cartridge and primed the inpen without issue. No harm requiring medical intervention was reported. The device is not expected to return for analysis.
 
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Brand NameINPEN MMT-105ELPKNA ELI LILY PINK
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 Key11599581
MDR Text Key244398513
Report Number3012822846-2021-00104
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
Reporter Occupation
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-105ELPKNA
Device Catalogue NumberMMT-105ELPKNA
Device Lot NumberB93GP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
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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