MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Model Number 6635747

Device Problem Protective Measures Problem (3015)

Patient Problem Hyperglycemia (1905)

Event Date 06/25/2022

Event Type  malfunction  

Event Description

I used a new libre freestyle sensor, lot # 6635747 s/n (b)(4).I followed the instructions and have used the product for five years plus.At first it worked, and i went to sleep and during the night check my blood glucose and it said check in ten minutes or something like that.I feel asleep and checked again a few hours later and same message.In the morning same message so i replaced it with new sensor.My bg was over 400, i was able to bring it down.When i picked up my rx for this product at cvs ((b)(6) 2022), bellport, ny and told the pharmacist what happened an she told me this happens, she can't help and call abbott on 1-855-632-8658.I called the number on (b)(6) 2022 at around 12:30 eastern time and first spoke with (b)(6) who could not help me.She transferred for "technical" help and i spoke with someone named (b)(6).She tried to help but could not articulate very well in english and had to repeat many medical questions that i did not understand.I asked her to transfer me to someone who spoke better english, but she refused and said nobody could help me and that my phone was the problem.In addition she said she was not licensed in medial care.(a quack).So i'm still not sure what happened but will discuss with my endocrinologist when i see her next.I want to report this as it seems abbott just sells things with no support or help for their patients.I did have high bg because of this, but was able to control it.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 14914645
• MDR Text Key: 295407045
• Report Number: MW5110655
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 0035759901018
• UDI-Public: 010035759901018
• 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: 06/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6635747
• Device Catalogue Number: 0M000LJET2M
• Device Lot Number: 6635747
• Patient Sequence Number: 1
• Treatment: INSULIN
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White