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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 Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypoglycemia (1912)
Event Date 01/18/2022
Event Type  Injury  
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
Customer reported via phone call that they were experiencing low blood glucose. Customer blood glucose was 35 mg/dl at the time of incident. Customer current blood glucose was 133 mg/dl. Customer stated that the insulin pen app was not recording doses. The insulin pen will not be returned for the 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 Key13342236
MDR Text Key284357826
Report Number3012822846-2022-00053
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000344
UDI-Public(01)000010862088000344(17)230202
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 10/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNBLNA
Device Catalogue NumberMMT-105NNBLNA
Device Lot NumberB94NR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/10/2022
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

Patient Treatment Data
Date Received: 01/25/2022 Patient Sequence Number: 1
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