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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problem Hyperglycemia (1905)
Event Date 01/19/2022
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
Information received by medtronic indicated that the insulin pen had a lead screw anomaly. Customer stated insulin pen took three to four times to get insulin come out and sometimes it does not deliver. Customer stated they threw the entire box and tried new needles but the issue reoccurred. Customer¿s blood glucose was 350 mg/dl. No harm requiring medical intervention was reported. The insulin pen will be returned for 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 Key13360461
MDR Text Key284508435
Report Number3012822846-2022-00057
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000368
UDI-Public(01)000010862088000368(17)221109
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 03/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2022
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 NumberB94BB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/23/2022
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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