Complaint follow-up

1st August 2005

Dear Sir,

Complaint Regarding the Ascensia Entrust Blood Glucometer

Thank you very much for brining your above complain to my attention. Your letter dated 23rd August was received in our office on 29th August and I have been out of the country and was back on 31st August midnight, I am attending to your letter as a first task on arriving on my office. I once again thank you for brining the situation to my notice enabling me to address the relevant issues separately.

1. Disparity between result of laboratory report and Glucometer result

The only method to identify the accuracy of a test result is when using control solutions. Control Solutions are internationally Accreditation solutions, which have known values. We shall be happy to perform a test using a control solution to whom the accuracy of the Ascensia Glucometer and the Strips used.

It is our protocol that every user at the time of purchase is demonstrated on how to do the test and discuss its limitations etc. even though it is detailed out in the user guide. However in some instances professional who are pressed for time opt to read the user guide and do it themselves without going through the "Sit-down Demonstration Procedures". Since your letter I shall insist that sales invoice should be processed only after the sit down demo procedure.

I am attaching herewith a document, which gives reasons for disparity between 2 test results of which samples are different to begin. The whole blood obtained from the capillary will have a slight various of blood glucose from the whole blood drawn from the vanes and the glucose level in whole blood will be different from the plasma etc.

2. Availability of Pack Size in 50'S

The Pack Size in 50'S has been decided as a best solutions to the professionals who used it as well as the patients by the manufactures for Sri Lanka due to economic reasons. The 25'S will be more costlier purchased by 20% - 30%. The patient monitoring protocol for diabetes to ensure good control measures one blood sugar test a day. As such it is been the accepted pack size which meets all logistics requirement for e.g. We as a Distributor have to order quantities which meets a minimum order requirement by the suppliers.

Having two pack sizes does not permit inventory maintenance of specified limits within the frame work of expiry limitations and minimum order quantities, and maintaining minimum cost per test for patients.

And also the diabetic patients are used to monitor their blood glucose daily in the monitoring or sometimes more than once in a day depend on doctor's advice. Therefore 50'S Strips packs are well being used within 50 days or less time.

One of our representatives will come and meet you in the due cause. We also welcome you to visit our office when you are in Colombo.

Thank you.

Yours faithfully,

ANALYTICAL INSTRUMENTS (PVT) LTD.,

K. Wijayaweera, C. Muthukumarage

Sales Administration Manager - Medical Division Director

c.c. Consumer Protection Authority
