Beurer GL50 evo
39
Results of the system accuracy for combined glucose concentrations between 36.0 mg/dL
(2.0 mmol/L) and 442.5 mg/dL (24.6 mmol/L).
Within ±15 mg/dL or ±15%
(within ±0.83 mmol/L or ±15%)
592/600 (98.67%)
In comparison to the YSI, the GL50 evo met the EN ISO 15197:2015 standard, whereby 95%
of the blood glucose values measured have to fall within the following zones: either ±15 mg/dL
(± 0.83 mmol/L) of the measured average values when using the reference measuring procedure for
blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations
of ≥100 mg/dL (≥5.55 mmol/L). 99% of the individual measured blood glucose values must fall within
zones A and B of the Consensus Error Grid (CEG) for diabetes type 1.
Performance evaluation by the user
A study to assess the glucose values of blood samples of capillary blood from the fingertips, which
were obtained from 103 individuals that had no special training, produced the following results:
96.7% within ±15 mg/dL (±0.83 mmol/L) and 95.9% within ±15% of the values obtained in the medical
laboratory with glucose concentrations of at least 100 mg/dL (5.55 mmol/L).
You will find further details and information regarding blood glucose results and various technologies
in generally relevant specialist medical literature.
11 u
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healthcare
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1. If the patient exhibits the following symptoms, it may be the case that no correct values can be
obtained:
• Acute dehydration
• Acute hypotension (low blood pressure)
• Shock
• Hyperosmolar hyperglycaemic condition (with or without ketosis)
2. Lipaemic samples: cholesterol levels up to 500 mg/dL (13 mmol/L) and triglyceride levels up to
1000 mg/dL (11.4 mmol/L) do not influence the results. Severely lipaemic blood samples were not
tested with the Beurer GL50 evo blood glucose monitoring system; therefore, using the device with
these samples is not recommended.
3. In the case of severely ill patients, blood glucose monitors for home use should not be used.
4. The effect of interfering substances on the measurements depends on the concentration in the
blood. The maximum concentrations of certain substances listed below do not significantly
influence the measurements.
