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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 No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 12/21/2021
Event Type  malfunction  
Event Description
Information received by medtronic indicated that the inpen had lead screw anomaly. The customer was reporting that she had put in a new cartridge and she primed the cartridge and nothing came out. She had tried a second time, she primed it 7 times before the insulin came out and she gave herself 15 units and at dinner time she primed and the insulin had not come out and she had to prime 7 more times. Customer had reported screw was not moving as intended. Customer stated that injection foot touching the plunger inside the cartridge. It was also reported that screw does not move when dose button was pushed. No harm requiring medical intervention was reported. 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 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
Information received by medtronic indicated that the inpen had lead screw anomaly. The customer was reporting that she had put in a new cartridge and she primed the cartridge and nothing came out. She had tried a second time, she primed it 7 times before the insulin came out and she gave herself 15 units and at dinner time she primed and the insulin had not come out and she had to prime 7 more times. Customer had reported screw was not moving as intended. Customer stated that injection foot touching the plunger inside the cartridge. It was also reported that screw does not move when dose button was pushed. No harm requiring medical intervention was reported. 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 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.
 
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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
tricha miles
1223 world trade drive, 100
san diego, CA 92128
7635140379
MDR Report Key13170723
MDR Text Key285536583
Report Number3012822846-2022-00012
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 01/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/29/2022
Device Model NumberMMT-105ELPKNA
Device Catalogue NumberMMT-105ELPKNA
Device Lot NumberB93KB
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? No
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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