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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105ELGYNA ELI LILY GRAY SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELGYNA
Device Problem Computer Software Problem (1112)
Patient Problem Hyperglycemia (1905)
Event Date 03/07/2021
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer's wife reported via phone call that there was an inaccuracy between the dose intended and dose recorded. The dose was greater than 1. 0 unit of insulin. Customer¿s blood glucose was 183 mg/dl. No harm requiring medical intervention was reported. The insulin pen will be returned for analysis.
 
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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
tricha miles
1223 world trade drive, 100
san diego, CA 92128
7635140379
MDR Report Key12139119
MDR Text Key262896685
Report Number3012822846-2021-00580
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,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105ELGYNA
Device Catalogue NumberMMT-105ELGYNA
Device Lot NumberB93NA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
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

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