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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN LINK 3 US SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED GUARDIAN LINK 3 US SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7911NA
Device Problems Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 05/03/2021
Event Type  malfunction  
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Brand NameGUARDIAN LINK 3 US
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 Key13735660
Report Number2032227-2022-128721
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 Date07/24/2021
Device Model NumberMMT-7911NA
Device Catalogue NumberMMT-7911NA
Device Lot Number1012518
Was Device Available for Evaluation? No
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? No
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

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