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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 Computer Software Problem (1112); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: n/a, software version: n/a, color: pink, battery life remaining: n/a. Customer reports: inpen not transmitting the correct dose to the app and sometimes not transferring the dose at all. Per visual inspection: missing injection foot. The inpen does not pair with commercial mobile. 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: the customer complaint of inpen not communicating with app is confirmed. However, dose log anomaly could not be confirmed due to communication anomaly. In addition: inpen will be sent to s. D for further analysis.
 
Event Description
Information received by medtronic indicated that the inpen app was not recording the exact doses dialed on the inpen. Customer stated that the inpen was not transmitting the correct dose to the app and sometimes did not transferred the dose at all. No harm requiring medical intervention was reported. The insulin pump was returned for analysis.
 
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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 Key13099332
MDR Text Key285213114
Report Number3012822846-2021-00902
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000337
UDI-Public(01)000010862088000337(17)230322
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,Followup
Report Date 03/30/2022
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-105ELPKNA
Device Catalogue NumberMMT-105ELPKNA
Device Lot NumberB95CH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2022
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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