FreeStyle Libre 2
ABBOTT DIABETES CARE INC · Model 71953
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
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
ECG lead-off / artifact
MediumSymptoms: Flat or noisy ECG, frequent lead-off alarms.
Root cause: Worn electrodes, loose leads, or dry gel.
SpO2 probe / sensor failure
MediumSymptoms: No pleth, SpO2 drops to --- or false low.
Root cause: LED/photodiode aging or cable damage.
NIBP measurement error
MediumSymptoms: Cuff fails to inflate, erroneous BP, long cycle.
Root cause: Pump/valve wear or cuff leak.
Internal battery depletion
HighSymptoms: Short backup time, battery alarm on transport.
Root cause: Aged backup battery.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
NIBP cuff & hose
Consumable per patient.
Class Periodic replacementRel. cost $R&R Easy
Rechargeable backup battery
Class Periodic replacementRel. cost $$R&R Fairly easy
Display / touch assembly
Class Periodic replacementRel. cost $$$R&R Difficult
ECG patient cable & lead set
High-turnover; keep inventory.
Class Frequent wear itemRel. cost $$R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| NIBP cuff & hose Consumable per patient. | Periodic replacement | $ | Easy |
| Rechargeable backup battery | Periodic replacement | $$ | Fairly easy |
| Display / touch assembly | Periodic replacement | $$$ | Difficult |
| ECG patient cable & lead set High-turnover; keep inventory. | Frequent wear item | $$ | 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 structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: ECG lead-off / artifact
- Confirm the presentation - typically flat or noisy ECG, frequent lead-off alarms - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: worn electrodes, loose leads, or dry gel.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the eCG patient cable & lead set per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: SpO2 probe / sensor failure
- Confirm the presentation - typically no pleth, SpO2 drops to --- or false low - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: lED/photodiode aging or cable damage.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the spO2 sensor (adult/ped/neo) per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Technical Specs
- Storage Environment Temperature
- -4°F to 140°F
- Storage Environment Atmospheric Pressure
- 70 KiloPascal to 106 KiloPascal
- Storage Environment Humidity
- 10 Percent (%) Relative Humidity to 90 Percent (%) Relative Humidity
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
- FDA product classification
- System, Test, Blood Glucose, Over The Counter; Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
- 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
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
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