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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 Problems Excess Flow or Over-Infusion (1311); Patient Device Interaction Problem (4001)
Patient Problem Hypoglycemia (1912)
Event Date 07/15/2021
Event Type  malfunction  
Manufacturer Narrative
The inpen screw retracts when dialing and advances when turning dose knob to the 0 mark and high resistance while dispensing due to dust/debris under the dose button, on washer, on the dose detent and dose knob. Unable to perform functional test due to leadscrew anomaly. Inpen received with missing dosing window.
 
Event Description
Information received by medtronic indicated the insulin pen user experienced low blood glucose because of over correcting due to unsure regarding the leadscrew. The user alleged the insulin pen was over delivering insulin. No harm requiring medical intervention was reported. The insulin pen was 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 Key12239563
MDR Text Key263863028
Report Number3012822846-2021-00614
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
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
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 NumberB93VJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
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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