TRUE METRIX AIR
TRIVIDIA HEALTH, INC. · Model TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE SYSTEM
Humana Pharmacy TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE SYSTEM.
Intended use: A collection of devices including a portable, battery-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 for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
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.
Will not power on or unexpected shutdown
HighSymptoms: The patient monitoring is dead, reboots, or shuts down mid-use.
Root cause: Mains lead / fuse, an aged battery, or a power-supply board fault.
Battery will not hold charge
MediumSymptoms: Short run time on battery; low-battery alarm soon after a full charge.
Root cause: Aged rechargeable battery pack or a charger fault.
Display / control-panel fault
MediumSymptoms: Blank, dim or distorted display; unresponsive keys or touchscreen.
Root cause: Display, backlight, or control-board fault.
Fails self-test or calibration
MediumSymptoms: Power-on self-test or the scheduled performance check fails or is out of tolerance.
Root cause: Sensor drift or an internal board fault; recalibration or repair needed.
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.
Rechargeable battery pack
Class Periodic replacementRel. cost $$R&R Fairly easy
Power supply / mains board
Class Major service partRel. cost $$$R&R Difficult
Display / control-panel assembly
Class Major service partRel. cost $$$R&R Moderate
Cooling fan
Class Major service partRel. cost $R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Rechargeable battery pack | Periodic replacement | $$ | Fairly easy |
| Power supply / mains board | Major service part | $$$ | Difficult |
| Display / control-panel assembly | Major service part | $$$ | Moderate |
| Cooling fan | Major service part | $ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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: Will not power on
- Confirm the outlet, mains lead and fuse.
- Try on battery, then on mains only, to isolate the supply.
- Look for a power indicator or POST code.
- Replace the fuse / battery / power supply as isolated.
- Run the self-test after any repair.
Symptom: Fails self-test or calibration
- Note the exact failure message / code.
- Power-cycle and repeat the self-test.
- Verify against a reference / simulator where one applies.
- Recalibrate per the service manual.
- Refer the affected board for service if it will not hold calibration.
Technical Specs
- Storage Environment Temperature
- 40°F to 86°F
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- OTC
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Glucose monitoring system IVD, home-use
- FDA product classification
- System, Test, Blood Glucose, Over The Counter
- Manufacturer support
- +1(800)803-6025 · customercare@trividiahealth.com
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- RECALL
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
- RECALL
One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL.
- RECALL
Product gives incorrect low blood glucose levels.
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