FreeStyle Lite
ABBOTT DIABETES CARE INC · Model 70804
FreeStyle Lite Blood Glucose Monitoring System.
Intended use: A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care.
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.
Inaccurate or questionable results
HighSymptoms: Result does not fit the clinical picture, poor agreement between duplicate strips, control solution out of range.
Root cause: Damaged, expired or wrong-lot strips, sample too small, or use outside the operating temperature range; haematocrit or interferents.
Meter error / strip problem message
MediumSymptoms: Error message on the display during or after a test.
Root cause: Faulty or mis-inserted strip, or a meter fault - repeat with a new strip.
Temperature out-of-range error
MediumSymptoms: Error stating the system is too hot or too cold.
Root cause: Meter and strips outside the specified operating range.
Will not power on / strip not detected
MediumSymptoms: No display on strip insertion, meter will not start a test.
Root cause: Depleted battery or worn / contaminated strip-port contacts.
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.
Battery
Class Frequent wear itemRel. cost $R&R Easy
Test strips
Single-use; observe the vial expiry and lot.
Class Frequent wear itemRel. cost $R&R Easy
Control solution
Class Frequent wear itemRel. cost $R&R Easy
Strip-port contact assembly
Class Periodic replacementRel. cost $$R&R Moderate
Lancing device
Class Periodic replacementRel. cost $R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Battery | Frequent wear item | $ | Easy |
| Test strips Single-use; observe the vial expiry and lot. | Frequent wear item | $ | Easy |
| Control solution | Frequent wear item | $ | Easy |
| Strip-port contact assembly | Periodic replacement | $$ | Moderate |
| Lancing device | 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: Result looks wrong
- Repeat with a new strip and an adequate sample.
- Run the control solution and compare to the range on the vial / insert.
- Check the ambient temperature is within range.
- Inspect the strip port for dirt, blood or moisture.
- If controls are out of range, quarantine the strip lot; if controls pass but patient results still look wrong, refer the meter.
Symptom: Error message on the display
- Turn the meter off and repeat the test with a new strip.
- Move the meter and strips to a location within the operating temperature range if a temperature error is shown.
- Inspect the strip port.
- Replace the battery.
- If the error recurs, contact customer service.
Technical Specs
- Storage Environment Temperature
- -4°F to 140°F
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- Yes
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Multiple clinical chemistry analyte monitoring system IVD, home-use
- FDA product classification
- SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER; Glucose dehydrogenase, glucose
- Manufacturer support
- +1(888)522-5226 · 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
Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.
- RECALL
Product dispositioned for destruction was potentially diverted to end users.
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