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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 Problem Communication or Transmission Problem (2896)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 05/06/2021
Event Type  malfunction  
Event Description
Medtronic indicated that no communication (unresolved) occurred. Customer reported loss of communication between the insulin pump and transmitter. The customer reported that they had low blood glucose. Customer did not report a loss of communication event that has been resolved and/or sensor has been removed. Customer stated at the time of event was 34 mg/dl. The customer did not experience any symptoms such as a result of low blood glucose. The customer declined troubleshooting for low blood glucose level. Customer was unconscious as he fell down on transmitter. It was unknown that if the insulin pump was in auto mode at the time of the incident.
 
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.
 
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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 Key13881941
MDR Text Key295815556
Report Number2032227-2022-170310
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 03/22/2022
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 Date05/11/2021
Device Model NumberMMT-7911NA
Device Catalogue NumberMMT-7911NA
Device Lot Number999687
Was Device Available for Evaluation? No
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/14/2020
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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