MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. ABBOTT FREESTYLE LIBRE 2 SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Event Description

Abbott freestyle libre 2 system sensor sends 10-15 loss of signal alarms daily although kept in pocket or within 5'.Abbott rep told me today problem caused by my body creating interference.On 3 separate occasions was unable to use reader to check blood sugar reading and received message to try in 10 minutes: at 12:40pm, 6:30pm and 11:11pm.Each time the reading was not available in 10 minutes; it took up to 3 hours.Today abbott rep explained 10 minutes means within 2 hours.These problems happen frequently and abbott is sending a replacement sensor, the second one since the start of the year.Also rep could not determine my status as long term user or past problems from records to which she had access.Fda safety report id # (b)(4).

• Brand Name: ABBOTT FREESTYLE LIBRE 2 SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 13600925
• MDR Text Key: 286372048
• Report Number: MW5107707
• Device Sequence Number: 2
• 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: 02/22/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: BABY ASPIRIN; GLUCAGON EMERGENCY KIT IF NEEDED; HUMALOG; LANTUS; LEVOTHYROXINE; RAMIPRIL; SIMVASTATIN; VITAMIN D
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White