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

Model Number FREESTYLE LIBRE 14 SENSOR PACK

Device Problems Product Quality Problem (1506); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Pain (1994)

Event Date 05/14/2020

Event Type  malfunction  

Event Description

Freestyle libre sensor, when placed on the back of the upper arm falls off and is unable to provide blood glucose data to the reader.This is not good.When the device sensor is ripped off the arm, such as when walking around a corner in a hallway it catches the edge of the corner and rips from the arm.After three times of this happening my arm became painful in the spot where the sensor was attached.I called abbott customer service to complain about the product, they took my data and are replacing the three sensors that came off.They suggested i get with a pharmacy to identify some sticky bandage covering that would prevent the sensor from being rubbed off.The pharmacy should supply the extra materials if their product has insufficient surface tackiness to remain on the skin.Bad product.Faulty product.May cause harm for diabetics that don't realize their blood glucose is extremely low.Get rid of the product or have the company redesign how it attaches to human skin."nuff said.It's a piece of crap." i don't like spending money or my insurance company money on faulty products.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10118649
• MDR Text Key: 194313651
• Report Number: MW5094833
• Device Sequence Number: 1
• 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: 06/01/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: FREESTYLE LIBRE 14 SENSOR PACK
• Device Catalogue Number: F96
• Device Lot Number: 0M0064
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 127