• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Hyperglycemia (1905)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter. Unit was able to charge, communicated and sync properly during rf association. However, unit failed accuracy test. No isig values were generated during testing; problem was isolated to electronic assembly.
 
Event Description
Medtronic received information that no communication (unresolved), charge/battery lasts less than expected occurred. There was no adverse impact or consequence reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13739436
MDR Text Key287201469
Report Number2032227-2022-129104
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 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2021
Device Model NumberMMT-7811NA
Device Catalogue NumberMMT-7811NA
Device Lot Number1004278
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2021
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-