MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 12/01/2019

Event Type  Injury  

Event Description

Patient called to report an adverse event involving his freestyle libre 14 day sensor.Patient stated on (b)(6) 2019, he put a new senor on, waited the correct time, and then received a higher than normal reading of 193.Patient said he waited an hour and took another reading and it went even higher into the 200¿s.Patient said he checked his blood sugar with test strips again and was only at 109.Patient stated he took a few more readings and all were over 200.Patient said he checked his blood sugar with the test strips again and it was only in the 80¿s.Patient said the sensor is completely off and consistently reading too high.Patient said he¿s previously reported this issue to abbott and has had this happen with at least 5 different sensors.

• Brand Name: FREESTYLE LIBRE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 9410912
• MDR Text Key: 169579070
• Report Number: MW5091421
• Device Sequence Number: 5
• 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: 12/03/2019
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR