Abbott FreeStyle Libre Repair

FreeStyle Libre User's Manual

The Abbott FreeStyle Libre Flash Monitoring device allows people with diabetes to track their sugar levels without constant finger-pricks. It uses a Continuous Glucose Monitoring (CGM) technology, which can automatically measure sugar levels every minute with its sensor and send this data to a handheld reader.

The video below provides a brief overview of the Abbot FreeStyle Libre system.

Video: What is continuous glucose monitoring and the benefits of CGM device (YouTube)

Abbott introduced the FreeStyle Libre in Europe in 2014. By 2017, it became the first diabetes monitoring system approved by the U.S. Food and Drug Administration (FDA) that didn’t require users to take blood samples for calibration. In 2022, the Galien Foundation honored the FreeStyle Libre technology as “the best of the best” since 1970. By that same year, around 4.5 million people around the world were using this technology to help manage their diabetes.

In 2023, Abbot issued a recall for all reader devices distributed beginning of November 2017. If charged with non-Abbot cables or adapters, the reader’s battery may get extremely hot, spark, or catch on fire. FDA recommends contacting Abbott’s Customer Service if the reader is damaged or if users need replacement USB cable or power adapter to charge their reader devices.

Sources:

• Abbot FreeStyle Libre Brief History
• Abbot's Galien Foundation Award Press Release
• FDA 2017 Approval
• FDA 2023 Recall
• FreeStyleLibre Official YouTube Channel

The FreeStyle Libre (original) Glucose Monitoring System has two main parts:

1. Handheld Reader: This is a small, portable device about the size of a modern smartphone, but thicker. It measures 95 mm by 60 mm by 16 mm. The front has a color touchscreen that lights up. There is a single, round blue Home button in the bottom right corner. On the device’s left edge, you will find a micro-USB port. On the bottom edge, there is a place for the test strip port.
2. Sensor Kit: This kit includes two parts: a sensor pack and a sensor applicator.
   1. The sensor pack looks like a small white tub with a peel-off lid. Inside, there is a sensor that is small, round, and white. It is 5 mm tall and 35 mm wide, similar to two stacked quarters. The sensor has a flexible tip that goes just under the skin.
   2. The sensor applicator is a disposable tool made of two plastic pieces. It has a shape like a cylinder with a plunger.

There are several models of FreeStyle Libre. To find out which model your reader is, check the label located on the front, just below the touch screen. The color of the reader can also help identify the model.

FreeStyle Libre (original)

• Label: FreeStyle Libre
• Color: Black

FreeStyle Libre 14-Day

• Label: FreeStyle Libre 14-Day
• Color: Black

FreeStyle Libre 2

• Label: FreeStyle Libre 2
• Color: Blue

FreeStyle Libre 3

• Label: FreeStyle Libre 3
• Color: Silver

Source: FreeStyle Libre User Manual, Abbot

• Blood glucose assay range: 1.1 to 27.8 mmol/L
• Blood ketone assay range: 0.0 to 8.0 mmol/L
• Reader size: 95 mm x 60 mm x 16 mm
• Reader weight: 65 grams
• Reader power source: One lithium-ion rechargeable battery
• Reader battery life: 7 days of typical use
• Reader memory: 90 days of typical use
• Reader operating temperature: 10 °C to 45 °C
• Reader storage temperature: -20 °C to 60 °C
• Operating and Storage relative humidity: 10-90%, non-condensing
• Reader moisture protection: Keep dry
• Operating and storage altitude: -381 metres (-1,250 ft) to 3,048 metres (10,000 ft)
• Reader display timeout: 60 seconds (120 seconds when test strip is inserted)
• Radio frequency: 13.56 MHz
• Data port: Micro USB
• Minimum computer requirements: System must only be used with EN60950-1 rated computers
• Mean service life: 3 years of typical use
• Power adapter: Abbot Diabetes Care PRT25612, operating temperature: 10 °C to 40 °C
• USB Cable: Abbot Diabetes Care PRT21373, length: 94 cm (37 inches)

• Sensor glucose assay method: Amperometric electrochemical sensor
• Sensor glucose reading: 2.2 to 27.8 mmol/L
• Sensor size: 5 mm height and 35 mm diameter
• Sensor weight: 5 grams
• Sensor power source: One silver oxide battery
• Sensor life: Up to 14 days
• Sensor memory: 8 hours (glucose readings stored every 15 minutes)
• Operating temperature: 10 °C to 45 °C
• Sensor applicator and sensor pack storage temperature: 4 °C to 30 °C
• Operating and storage relative humidity: 10-90%, non-condensing
• Sensor water resistance: IP27: can withstand immersion into one metre (3 ft) of water for up to 30 minutes
• Operating and storage altitude: -381 metres (-1,250 ft) to 3,048 metres (10,000 ft)

 Source: FreeStyle Libre User Manual

• Abbot’s information on FreeStyle Libre models and applications
• The Official Abbot FreeStyle Product Page

• Setting Up (YouTube video)
• Reading Glucose Levels (YouTube video)
• Replacing Sensor (YouTube video)

• Abbot Freestyle Libre 3 Review by CNBC (YouTube video)