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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 Insufficient Information (4580)
Event Date 08/17/2021
Event Type  malfunction  
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
Information received by medtronic indicated that the inpen had dose log inaccuracy concern reported by customer dose amount displayed in logbook for dose in question 4. 5 12. 5 was intended dose amount and dose amount recorded in the inpen app greater than 1. 0 unit. No harm requiring medical intervention was reported. The insulin pump will not be returned for analysis.
 
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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 Key12375994
MDR Text Key270044725
Report Number3012822846-2021-00689
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,Followup,Followup,Followup,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/28/2021
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

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