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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN

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COMPANION MEDICAL INC INPEN Back to Search Results
Model Number IN-PEN
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Hypoglycemia (1912)
Event Date 12/14/2021
Event Type  Injury  
Event Description
The customer reported via phone call that they experienced low blood glucose level. The customers blood glucose was 50 mg/dl. Customer reported that the insulin cartridge has not been exposed to extreme temperatures and it was not expired. The device will not be returned for analysis.
 
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.
 
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Brand NameINPEN
Type of DeviceINPEN
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 Key13101672
MDR Text Key283097478
Report Number2032227-2021-236208
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 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIN-PEN
Device Catalogue NumberIN-PEN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/30/2021
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: 12/28/2021 Patient Sequence Number: 1
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