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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNBLNA
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2021
Event Type  malfunction  
Manufacturer Narrative
Serial number: (b)(4). Software version: (b)(4). Color: blue. Battery life remaining: <2 months. Unit paired successfully to commercial mobile app. My inpen menu displayed: the following test values were dialed and dosed: two 30 units values were dialed and 6. U and 21. 0 u were recorded. The inpen values of 30 units transmitted did not matched bolus dialed due to contamination at encoder. Inpen received with erased dose nut marker and dose window. Unable to dial any specific dose number due to erased dose nut marker. Dust/debris was observed under the dose button, the dose detent, the dose knob, encoder pattern wheel, encoder contact support, encoder contact pcba and electronic assembly was noted per visual inspection. Unit received with broken off piece at the cartridge holder. The cartridge holder did not lock in place. Inpen received with missing dosing window.
 
Event Description
The customer reported via phone call that the cartridge holder on their insulin pen was cracked and was no longer injecting the amount of insulin they were dialing up to. No harm requiring medical intervention was reported. The insulin pen was returned for analysis.
 
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Brand NameINPEN MMT-105NNBLNA NOVO NORDISK 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 Key12086779
MDR Text Key261693272
Report Number3012822846-2021-00556
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 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNBLNA
Device Catalogue NumberMMT-105NNBLNA
Device Lot NumberB92MR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
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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