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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELBLNA
Device Problem Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: n/a, software version: n/a, color: blue, battery life remaining: n/a. Customer reports: broken/damaged cartridge holder. Per visual inspection: broken off piece at the cartridge holder. Inpen received with leadscrew halfway of the travel. Re-wound screw. No drag was observed, the screw was not bent, advanced when dosage knob was pressed dialing a dosage and retracted appropriately. No resistance was observed when dosing without a cartridge installed. The screw advanced every time 30. 0u was dialed and dosed until the screw reached max extension. In conclusion: inpen received with broken off piece at the cartridge holder. The cartridge holder did not lock in place. The customer complaint of physical damage was confirmed.
 
Event Description
Information received by medtronic indicated that the inpen cartridge holder was broken and sometimes it was not delivered the correct amount of insulin. No harm requiring medical intervention was reported. The device was returned for analysis.
 
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Brand NameINPEN MMT-105ELBLNA ELI LILY BLUE
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 Key13502360
MDR Text Key288023409
Report Number3012822846-2022-00097
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 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105ELBLNA
Device Catalogue NumberMMT-105ELBLNA
Device Lot NumberB93UC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Date Manufacturer Received01/24/2022
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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