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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 Break (1069); Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 08/17/2020
Event Type  malfunction  
Manufacturer Narrative
Driver screw did not move when dialing in dosage.When dosage knob was pressed in driver screw extended outward.
 
Event Description
Information received by medtronic indicated that the insulin pen stopped working.Customer stated that they changed cartridge and tried to prime pen but they could not press the dose button anymore.No harm requiring medical intervention was reported.The insulin pen will not be returned for analysis.
 
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Brand Name
INPEN MMT-105ELPKNA ELI LILY PINK
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 Key12291368
MDR Text Key267258944
Report Number3012822846-2021-00635
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000337
UDI-Public(01)000010862088000337(10)B93BC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-105ELPKNA
Device Catalogue NumberMMT-105ELPKNA
Device Lot NumberB93BC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2020
Date Manufacturer Received08/04/2021
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 Unknown
Patient Sequence Number1
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