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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 07/01/2021
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 they were in emergency room and hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2021. Customer's blood glucose levl was 400 mg/dl at the time of event and 280 mg/dl at the time of call. Customer stated that they were having symptoms like nausea, vomiting, abdominal pain, difficulty in breathing. Customer stated that they were treated with inpen doses. Customer stated that inpen foot was very loose. Customer was assisted with insulin delivery by dispensing 2 units prime in air and insulin did exists. The device 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 Key12211986
MDR Text Key262953509
Report Number3012822846-2021-00609
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 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-105NNPKNA
Device Catalogue NumberMMT-105NNPKNA
Device Lot NumberB93TJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
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: 07/22/2021 Patient Sequence Number: 1
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