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

Lot Number HG3X75O

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Calibration Problem (2890); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 11/14/2019

Event Type  malfunction  

Event Description

Reporter advised he is frustrated and discouraged with his device.He alleges that for the past four months the sensors have not been functioning properly.He has experienced errors, calibration issues, false and out of range results.He does not feel safe using the device and they don't last for 7 days as specified by the mfr.Reporter advised this caused him to change sensors frequently causing bleeding and discomfort.He has reported to the mfr and he believes the fda needs to investigate the device.He believes there is a product quality problem and thinks the sensors and possibly the transmitter are out of spec.

• Brand Name: GUARDIAN SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 9720713
• MDR Text Key: 180043530
• Report Number: MW5093025
• Device Sequence Number: 2
• 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: 02/14/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: HG3X75O
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR