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

Model Number MMT-7020

Device Problems Product Quality Problem (1506); Low Readings (2460)

Patient Problem Anxiety (2328)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Inaccurate glucose reading; while using the minimed 770g insulin pump and glucose sensor i kept receiving erroneous glucose levels variance of up to 200 mg/dl.Several times i have been awaken with urgent low warnings of between 47 and 63 only to discover that my bg was actually 103 - 140.The pump tells me to calibrate and i do, only for the pump to tell me calibration not accepted and change sensor.I have worked with the company to replace sensors but it seems only about 20% of sensors last the 7 days they are supposed to.Most need to be replaced the day of insertion.I have varied sensor locations, changed batteries, had assistance with insertion, and followed tech rep instructions, and user guide instructions to no avail.On (b)(6) 2022, i called to get replacements for bad sensors and had a total of 5 bad ones from (b)(6) 2022.In that time i had 1 sensor that performed for the full 7 days it was supposed to.The failure rate among these is causing me great anxiety and frustration to the point i no longer wish to mess with the sensor at all.I have used a dexcom sensor in the past with no significant problems so i do not believe it is user error but more likely a defective product.Various lots number.Fda safety report id # (b)(4).

• Brand Name: GUARDIAN SENSOR 3
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 14168644
• MDR Text Key: 289907858
• Report Number: MW5109214
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/18/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7020
• Device Catalogue Number: MMT-7020A
• Device Lot Number: VARIOUS
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; CYCLOBENZAPRINE; ERGOCALCIF; LISINOPRIL; MELODIC; METFORMIN ; MINIMED 770G INSULIN PUMP; NOVOLOG; TYLENOL
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White