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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED STARTER KIT MMT-7821WW GST4C OUS; SENSOR, GLUCOSE, INVASIVE
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MEDTRONIC MINIMED STARTER KIT MMT-7821WW GST4C OUS; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7821WW
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 02/22/2021
Event Type  malfunction  
Event Description
Medtronic received information that no communication (unresolved) occurred.
 
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 Name
STARTER KIT MMT-7821WW GST4C OUS
Type of Device
SENSOR, 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 Key13847904
MDR Text Key291941122
Report Number2032227-2022-169090
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-7821WW
Device Catalogue NumberMMT-7821WW
Device Lot NumberA000780713
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2021
Date Device Manufactured03/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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