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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED XMTR MMT-7811NA GST3C LOCKOUT SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED XMTR MMT-7811NA GST3C LOCKOUT SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7811NA
Device Problems Battery Problem (2885); Communication or Transmission Problem (2896)
Patient Problem Skin Erosion (2075)
Event Date 03/03/2021
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 lost sensor alarm, charge/battery lasts less than expected, no communication (unresolved) occurred. There was no adverse impact or consequence reported as a result of this event.
 
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Brand NameXMTR MMT-7811NA GST3C LOCKOUT
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
tricha miles
18000 devonshire st.
northridge, CA 91325
7635140379
MDR Report Key13874769
MDR Text Key287853058
Report Number2032227-2022-161357
Device Sequence Number1
Product Code MDS
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 03/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Model NumberMMT-7811NA
Device Catalogue NumberMMT-7811NA
Device Lot Number1002373
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/05/2021
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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