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

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problems Headache (1880); Hyperglycemia (1905); Unspecified Eye / Vision Problem (4471)

Event Date 04/01/2023

Event Type  Injury  

Event Description

I got a freestyle libre 14 days meter for my diabetic blood sugar to check my a1c blood, and it was up to in the high 468 to about 500.Because this free style libre 14 day was defected and a recall on them, feeling bad and concern, i was sick, i have cancer and no pancreas and "part stomach".So i want to be compensated for damage on this freestyle libre 14 day.So if you could contact this company for me for damage, headache, vision problems, and other thing going on because of this testing my sugar a1c.I want to be paid for damages because of defected free style libre 14 day.Write me a letter to (b)(6).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 16929999
• MDR Text Key: 315281544
• Report Number: MW5117511
• Device Sequence Number: 1
• Product Code: PZE
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: INSULIN
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: White, American Indian Or Alaskan Native