FreeStyle Libre 2
ABBOTT DIABETES CARE INC · Model 71951
FreeStyle Libre 2 Flash Glucose Monitoring System Reader.
Intended use: An assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
Key tips
- ·A no-signal/flatline alarm gets checked on the patient first, not the monitor - rule out a real clinical event before troubleshooting.
- ·Recalibrate NIBP against a reference manometer, not just a self-test pass.
- ·Reused patient cables (SpO2, ECG leads) are a common source of intermittent-fault complaints - swap the cable before the module.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Sensor will not start or gives no readings
HighSymptoms: Reader / app does not detect the sensor, no glucose value on scan, sensor-error message.
Root cause: Sensor still in warm-up, a damaged or improperly applied sensor, or scanning near metal / strong RF.
Problems at the application site
MediumSymptoms: Sensor lifting, bleeding, irritation, or falls off early.
Root cause: Poor adhesion (site not clean / dry), applied over hair or a bony area, or knocked during wear.
Reader will not power on or hold charge
MediumSymptoms: Blank reader, will not turn on, short battery life.
Root cause: Depleted internal battery or a charging-port / cable fault.
Reader / phone-app connectivity fault
MediumSymptoms: Reader or app will not pair or sync, alarms not delivered.
Root cause: Bluetooth pairing, a phone OS / app issue, or (per Abbott recalls) a certificate / firmware fault.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Reader (rechargeable)
Class Periodic replacementRel. cost $$R&R Easy
Sensor
Single-use; replace on error or at end of wear.
Class ConsumableRel. cost $R&R Easy
Sensor applicator
Class ConsumableRel. cost $R&R Easy
USB charging cable
Class Periodic replacementRel. cost $R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Reader (rechargeable) | Periodic replacement | $$ | Easy |
| Sensor Single-use; replace on error or at end of wear. | Consumable | $ | Easy |
| Sensor applicator | Consumable | $ | Easy |
| USB charging cable | Periodic replacement | $ | Easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Routine cable and lead-wire inspection for fraying/wear
- ·Battery conditioning cycle
- ·NIBP calibration check against a reference manometer
- ·ECG / SpO2 accuracy verification against a patient simulator
- ·Annual electrical safety test
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Sensor will not start / no readings
- Wait the full warm-up period after application.
- Hold the reader within a few cm of the sensor, away from metal.
- If a sensor error is shown, note any code and apply a new sensor to a clean, dry, hairless area on the back of the upper arm.
- Run a reader self-test from the settings menu.
- Contact Abbott customer service with the sensor serial and error if a new sensor also fails.
Symptom: Reader will not power on
- Charge for at least a few hours with the supplied cable and a known-good USB source.
- Try another cable / charger.
- Note the run time from a full charge.
- Perform a reader test if it powers up.
- Replace the reader if it will not hold charge.
Technical Specs
- Storage Environment Temperature
- -4°F to 140°F
- Storage Environment Humidity
- 10 Percent (%) Relative Humidity to 90 Percent (%) Relative Humidity
- Storage Environment Atmospheric Pressure
- 70 KiloPascal to 106 KiloPascal
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
- FDA product classification
- Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems; System, test, blood glucose, over the counter
- Manufacturer support
- +1(855)632-8658 · xx@xx.xx
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- ICU / CCU
- Emergency Department
- OR / PACU
- General med-surg floors
- Step-down units
- Telemetry units
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
- RECALL
Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with signif
- RECALL
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
- RECALL
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
- RECALL
If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.
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