Troubleshooting identified that the customer did not perform check strip (quality check) on the analyzer prior to testing.During troubleshooting, the check strip test failed which indicates the analyzer should not be used.The customer returned the analyzer for investigation.The returned analyzer exhibited glucose results within zone b of the glucose consensus error grid however on the lower end thus prompting this incident to be reported out of an abundance of caution.Qc retention was tested and measured well within specification.See medical opinion: with regard to under-recovery of glucose, a small error would not affect any clinical decisions.A large error (even ignoring lack of signs and symptoms of hypoglycemia) would pose no risk to the patient (with the provision of oral carbohydrates).
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