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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC SFTWR MMT-8060 INPEN APP IOS

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COMPANION MEDICAL INC SFTWR MMT-8060 INPEN APP IOS Back to Search Results
Model Number MMT-8060
Device Problem Computer Software Problem (1112)
Patient Problem Hyperglycemia (1905)
Event Date 12/19/2021
Event Type  malfunction  
Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter. 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
Medtronic received information that software error occurred. There was no adverse impact or consequence reported as a result of this event.
 
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Brand NameSFTWR MMT-8060 INPEN APP IOS
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 Key13847736
MDR Text Key287613074
Report Number3012822846-2022-00368
Device Sequence Number1
Product Code NDC
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
Report Date 03/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-8060
Device Catalogue NumberMMT-8060
Was Device Available for Evaluation? No
Date Manufacturer Received12/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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