One fatality has already occurred as a result of the masking effects of the metabolites of maltose and icodextrin on glucose monitoring strips with the Accu-Chek Advantage
The Medicines and Healthcare Products Regulatory Agency (MHPRA) has recently issued a warning to NHS and Primary Care trusts in England regarding the safety of results obtained by the Roche Accu-Chek Advantage ll blood glucose meter test strips when used for diabetics ingesting maltose as part of their diet or whose treatment regime involves icodextrin.
Icodextrin is frequently prescribed for renal patients on Continuous Ambulatory Peritoneal Dialysis (CAPD) and it is clear that in these patients, maltose or the metabolites of maltose and icodextrin can constitute dangerous interference to glucose readings on certain meters, leading to an overestimation of the amount of glucose circulating in the blood and the potential for inappropriate administration of insulin.
In some cases this interference may mask hypoglycaemia, and one fatality - believed to be the first in the UK - has already occurred, with two further adverse incidents reported.
Recent extensive studies confirm that there is no potential interference to glucose measurements from icodextrin, maltose or their metabolites when using the HemoCue B-Glucose analyser.
This provides rapid, easy and reliable measurements whenever and wherever required - and the technique is simple.
The measurement system consists of a portable photometric analyser and disposable self-filling cuvettes containing the dry reagents. The cuvette draws up exactly 5ul of blood by capillary action and is placed in the photometer while the chemical reaction takes place.
Results are displayed within 60 seconds while the patient waits, and with the help of liquid controls and an internal self-test verifying accuracy and linearity at three points, the quality of all measurements can always be relied upon.
Despite the warning on the product insert for the Roche Accu-Chek Advantage ll that maltose can interfere with readings, the MHPRA statement refers to adverse incident reports where users have sometimes been unaware of such limitations.
In line with HemoCue's long term recommendations, the MHPRA stipulates that all point-of-care blood glucose monitoring systems must carry detailed information on any limitations, and that these should also be highlighted in any training material.
If users are in doubt about a particular system or the validity of test results, they should consult the hospital or their local clinical chemistry department.
