Accu-Chek Instant test strips together with Accu-Chek Instant and Accu-Chek Instant S glucometers are intended for the quantitative determination of glucose in fresh capillary whole blood obtained from a finger, palm, forearm and upper arm as an aid in monitoring the effectiveness of glucose control.
Accu-Chek Instant test strips together with Accu-Chek Instant and Accu-Chek Instant C glucometers are intended for in vitro diagnostics for self-monitoring by patients with diabetes.
Accu-Chek Instant test strips together with Accu-Chek Instant and Accu-Chek Instant C glucometers are intended for in vitro diagnostics by doctors in a clinical setting. Only doctors can use venous, arterial and neonatal blood.
This system is not intended for the diagnosis of diabetes mellitus or the analysis of neonatal cord blood samples.
Equipment
Packaging containing test strips and inserts.
All packaging components can be disposed of with household waste. Dispose of used test strips according to local regulations. If you have any questions, please contact Roche.
People with diabetes: Talk to your doctor about the blood glucose range that is appropriate for you. You should treat low or high blood glucose levels as directed by your doctor.
Unusual blood glucose results
If your meter shows LO, your blood glucose level may be below 0.6 mmol/L (10 mg/dL). If your meter shows HI, your blood glucose level may be higher than 33.3 mmol/L (600 mg/dL). For more error information, see the User Guide.
If your blood glucose test result does not correspond to how you feel, follow these steps:
Repeat the blood glucose test with a new test strip.
Perform a control determination as described in the user manual.
For other reasons, see your user manual.
If your symptoms still do not match your blood glucose test results, contact your doctor.
Never ignore symptoms or make significant changes to your diabetes management program without consulting your doctor.
Limitation
Lipemic samples (triglycerides) >20.3 mmol/L (>1800 mg/dL) may result in elevated blood glucose results.
Do not use this system during a xylose absorption test.
Do not use this system if you are receiving ascorbic acid intravenously.
In patients with peripheral circulatory impairment, capillary blood collection from approved sampling sites is not recommended as the results may not correspond to physiological blood glucose levels. This may occur under the following conditions: Severe dehydration due to diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome without ketoacidosis, hypotension, shock, NYHA class 4 decompensated heart failure, or peripheral arterial occlusive disease.
The hematocrit should be between 10 and 65%. If you don’t know your hematocrit, ask your doctor.
This system has been tested at altitudes up to 3094 meters above sea level.
Recommendations for use
The Accu-Chek Instant system meets the requirements of ISO 15197:2013 (In vitro diagnostic test systems – requirements for blood glucose monitoring systems intended for self-monitoring of blood glucose levels in the management of diabetes mellitus).
Calibration and tracking:
The system (meter and test strips) is calibrated using venous blood containing varying concentrations of glucose as a calibration aid. Control values were obtained using the hexokinase method calibrated using the ID‑GCMS method. The ID‑GCMS method, as a method of the highest metrological quality (order), complies with the NIST core standard. Using such a traceability chain, the result obtained from such control solution test strips can also be traceable to the NIST standard (traceable).
Lower limit of determination (lowest value):
0.6 mmol/L (10 mg/dL) for test strip
System detection range:
0.6–33.3 mmol/L (10–600 mg/dL)
Sample volume:
0.6 µl
Determination time:
<4 seconds Manufacturer Roche Diabetes Care GmbH, Andhofer Strasse 116 68305, Mannheim, Germany .
