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

Model Number MMT-7020A

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2019

Event Type  Injury  

Event Description

The medtronic guardian 3 cgm malfunctioned and stopped giving reading.The sensor was replaced with a new sensor with the same results.It was also inaccurate when compared to my meter.Fda safety report id# (b)(4).

• Brand Name: GUARDIAN 3 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 8970258
• MDR Text Key: 157067300
• Report Number: MW5089599
• Device Sequence Number: 0
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2020
• Device Model Number: MMT-7020A
• Device Lot Number: HG3FHRY
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 91