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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 No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Nausea (1970)
Event Date 09/18/2021
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. 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
The customer reported via phone call that the customer experienced high and low blood glucose levels. The customer blood glucose level was 481 mg/dl at time of incident and the current blood glucose level was 46 mg/dl. Customer reported that her insulin pen was not delivering insulin. Customer reported symptoms of nausea and fatigue. The customer was assisted with troubleshooting. The customer was treated with manual injection for high blood glucose levels. Customer stated that insulin exited. The device will be 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 Key12519664
MDR Text Key272923239
Report Number3012822846-2021-00739
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 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-105NNBLNA
Device Catalogue NumberMMT-105NNBLNA
Device Lot NumberB93MJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
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

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
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