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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON

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COMPANION MEDICAL INC INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNPKNA
Device Problem Computer Software Problem (1112)
Patient Problem Insufficient Information (4580)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
Information received by medtronic indicated that the lead screw was damaged. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Serial number: (b)(4), software version: 3. 8. 3, color: pink, battery life remaining: <3 months. Customer reports: inpen app is not recording the exact doses dialed on the inpen, the dose is not showing in the active insulin. Per visual inspection: received with missing dosing window. Unit paired successfully to commercial app. My inpen menu displayed: the following test values were dialed and dosed: 4. 0u, 4. 0u, 4. 0u, 4. 0u and 16. 0u. All values displayed accurately in the logbook. All doses were written to the app logbook within 1 minute. 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 working as design. No malfunctions noted during testing that could affect insulin delivery. The patient complaint of dose log inaccuracies or not showing the active insulin could not be confirmed. Inpen will be sent to s. D for further analysis.
 
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Brand NameINPEN MMT-105NNPKNA NOVO NORDISK 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 Key13101403
MDR Text Key285223132
Report Number3012822846-2021-00903
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,Followup
Report Date 02/21/2022
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-105NNPKNA
Device Catalogue NumberMMT-105NNPKNA
Device Lot NumberB92LH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received02/16/2022
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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