MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC GUARDIAN SENSOR (3); AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-7020A
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic guardian sensor (3) failed.Inserted a new sensor on the morning of (b)(6) 2021 and was going through the calibration process.The sensor reading at 9:01 pm was 113 and my actual bg was 193.I have now had 6 out of 9 sensors of lot hg50luf (ref (b)(4)) fail.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC GUARDIAN SENSOR (3)
• Common Device Name: AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 11568461
• Report Number: MW5100253
• Device Sequence Number: 3622497
• Product Code: OZP
• UDI-Device Identifier: 20763000337005
• UDI-Public: (01)20763000337005
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/22/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/15/2022
• Device Model Number: MMT-7020A
• Device Catalogue Number: G12260-18
• Device Lot Number: HG50LUF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 86