MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREE STYLE LIBRE CONTINUOUS GLUCOSE MONITOR 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problems Loss of or Failure to Bond (1068); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/23/2019

Event Type  malfunction  

Event Description

The accuracy and reliability of the free style libre 14 day sensor is suspect especially after 10 days.I have noticed the scan reading and the finger stick reading can be up to 80 units off.I have seen it from 2 days after applying to 10 days after applying before the discrepancies.The company only offers a replacement.Typically i have taken the finger stick and compared to screen readings when the screen reading show a steady level.Not all sensors failed but a majority of them do.Also, my skin does not allow for the sensor to stay on especially when humid and i am working outdoors.Based on the scan readings, i do not take medicine which shows high a1cs.Fda safety report id# (b)(4).

• Brand Name: FREE STYLE LIBRE CONTINUOUS GLUCOSE MONITOR 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 9150962
• MDR Text Key: 161370994
• Report Number: MW5090190
• 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: Other
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 136