MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. LIBRE CGM SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Lot Number T60001636

Patient Problems Erythema (1840); Hyperglycemia (1905); Dry Mouth (4485); Skin Inflammation/ Irritation (4545)

Event Date 02/01/2024

Event Type  Injury  

Event Description

Patient called to report a product issue and adverse event involving 3 abbott libre sensors.Patient stated she started using the device approximately 6 weeks ago and that her first sensor fell off after only 4 days.She stated the second sensor stayed on the full 14 days but gave false information and inaccurate readings.Patient stated the sensor alarmed 7 times for low, but only 1 of those times was she low.She also said she noticed the sensor site become red and irritated.Patient said she inserted a third sensor and wore it only 9 days and woke up with a very dry mouth and saw the glucometer said high.Patient checked with a finger stick, and it was 450 which was much higher than the sensor reading.Patient said she treated with insulin and then the glucometer alarmed critically low with a reading of 53, she again checked with a finger stick, and it was still way off.Patient stated for some reason the device isn¿t registering the correct amount of insulin and is giving false readings.Patient stated the sensors were applied correctly and occlusive to the skin.After the third sensor came off, she stated she still has a 3-inch circle with a raised, hard dot in the middle that¿s red and irritated.Patient stated she has put on the 4th sensor and is hoping it will work better than the first 3 did.Reference reports: mw5152944, mw5152945.

• Brand Name: LIBRE CGM SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 18928942
• MDR Text Key: 338146167
• Report Number: MW5152943
• Device Sequence Number: 1
• Product Code: QLG
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: T60001636
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female