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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNGYNA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
The inpen screw retracts when dialing and advances when turning dose knob to the 0 mark and high resistance while dispensing due to dust/debris under the dose button, on washer, on the dose detent and dose knob. Unable to perform functional test due to leadscrew anomaly. No cosmetic damage was noted.
 
Event Description
The customer reported via phone call that they were having issue with the insulin pen. Customer primed the insulin pen multiple times, replaced the needles and the cartridge, but the issue was not resolved. Customer¿s blood glucose was 369 mg/dl. No harm requiring medical intervention was reported. The insulin pen will be returned for analysis.
 
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Brand NameINPEN MMT-105NNGYNA NOVO NORDISK GRAY
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 Key12258975
MDR Text Key264494369
Report Number3012822846-2021-00621
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 08/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNGYNA
Device Catalogue NumberMMT-105NNGYNA
Device Lot NumberB94UP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
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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