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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 11/08/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: n/a, software version: n/a, color: blue, battery life remaining: n/a. Customer reports: piece from the cartridge that slips into the pen broke. Per visual inspection: broken off piece at the cartridge holder. Inpen received with leadscrew fully rewound. The leadscrew 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: the cartridge holder did not locked properly. The customer complaint of physical damage to cartridge holder is confirmed.
 
Event Description
Information received by medtronic indicated that the piece from the cartridge that slips into the pen broke. Customer said they were trying to dose and it slipped so they tried again and it slipped again. Customer reported broken cartridge insulin. No harm requiring medical intervention was reported. The insulin pump 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 Key13101664
MDR Text Key285222755
Report Number3012822846-2021-00907
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 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
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 NumberA92NG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Date Manufacturer Received12/14/2021
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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