LETTERS
References hospitals (Birmingham) all have unmodified original meters and have yet to We originally informed Bayer of our Andrew C.J. Hutchesson From the middle of 1995, all meters findings in late 1994, at about the same Department of Clinical Chemistry, The were manufactured with a modified test time as the draft MDA report was available Children's Hospital, Birmingham B16 8ET slide which prevented an erroneous result to them, and the user guide was subbeing obtained. Bayer employees were sequently modified to state that the meter able to implement the upgrade for hospishould only be used on a flat surface. tals using modified test slides.
References When a representative from Bayer showed We have never received a report of a us the new user guide we were told that Glucometer 4 user having this problem modification of the meter depended on 1. Martin SC, Hutchesson ACJ. Aberrant and the MDA and DOH were satisfied decisions within the American parent results due to incorrect use of the that our user instructions clearly alerted company. We presented our findings in Bayer Glucometer 4 meter (letter). users to the issue, which was resolved May 1995, 3 at the same meeting a modi-Diabetic Med 1996; 13: 594. rapidly as soon as we became aware of it.
fied meter (the only one in the UK) was 2. Batki AD, Thomason HL, Holder The recent letter by Dr S.C. Martin and demonstrated to us. We were concerned R, Thorpe GHG. MDA Evaluation Dr A.C.J. Hutchesson will only serve to that there was no external means of Report: Bayer Glucometer 4 Glucose cause unnecessary concern among the distinguishing between the original and Meter. London: Medical Devices many thousands of Glucometer 4 users modified meters. Agency, 1994. who have not been affected by this Bayer state in their letter that all meters 3. Martin SC, Hutchesson ACJ. An evaluoccurrence and will not be of any benefit from the middle of 1995 have been of ation of the Bayer Glucometer 4 to those who have already been alerted the modified type and that their employees glucose meter. In: Martin SM, Halloto this resolved problem.
were able to modify the meters already ran SP, Green AJE. Proceedings of the ACB National Meeting. Focus