Dear Colleagues
We have identified a serious flaw with a batch of Olympus trigyceride
reagent (Lot 9444) running on our Olympus analysers. The reagent is meant to
give a linear response up to 11 mmol/L but failed to trigger dilution on
high samples (>5) producing grossly underestimated results. This became
apparent when an obviously lipaemic sample was reanalysed at dilution and
was also resulted correctly when analysed with a different reagent batch
(Lot 9785), as follows:
Lot Lot diff
9444 9785 d-c %
4.6 5 8.7
6.5 24.2 272.3
4.7 5 6.4
6.4 10 56.3
5.8 7.2 24.1
6.2 9.6 54.8
4.5 4.8 6.7
4.8 5.6 16.7
5.6 5.5 -1.8
5.0 5.7 14.0
5.5 6.6 20.0
5.5 6.3 14.5
6.7 20 198.5
6.3 8.8 39.7
6.3 7.4 17.5
5.5 6.6 20.0
6.2 8.3 33.9
6.3 10.7 69.8
4.6 4.8 4.3
6.2 7.0 12.9
6.1 7.0 14.8
6.1 7.0 14.8
6.3 7.3 15.9
6.2 7.5 21.0
5.8 7.2 24.1
6.0 7.6 26.7
6.7 9.6 43.3
6.9 10.4 50.7
6.1 9.4 54.1
6.7 38.6 476.1
The last one is clearly at risk of pancreatitis which would not have been a
concern with the lower erroneously reported value. Olympus and MDA have been
informed and users can expect to receive a bulletin about the problem batch
in the next few days, but I felt this couldn't wait any longer. The batch
may have "gone off" while in service so it may not have been initially
apparent.
Dermot
PS I'm off home now, it's been a hard week.
******************************************
Dr RDG Neely
Consultant Chemical Pathologist
Department of Clinical Biochemistry
Newcastle upon Tyne Hospitals NHS Trust
Royal Victoria Infirmary
Newcastle upon Tyne NE1 4LP
Tel. 0191 2824554 Fax. 0191 2820381
[mailto:[log in to unmask]]
*******************************************
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