The customer stated that they received erroneous results for one patient sample tested for elecsys insulin (ins) on a cobas 6000 e 601 module (e601).The sample initially resulted as 1.05 uu/ml accompanied by a data flag on the e601 analyzer (reference range = 2.6 - 24.9 uu/ml).The initial value was reported outside of the laboratory.The sample was repeated on the e601 analyzer, resulting as 0.970 uu/ml accompanied by a data flag.On (b)(6) 2017, the sample was repeated on an abbott architect four times, resulting as follows: 227.7 uu/ml, 227 uu/ml, 218 uu/ml, and 228 uu/ml (reference range = 2.0 - 23.0 uu/ml).A sample collected at the same time as the original sample was tested on the e601 analyzer on (b)(6) 2017, resulting as 0.85 uu/ml.Two samples collected at the same time as the original sample were also repeated on the abbott architect analyzer on (b)(6) 2017, with each resulting as 223.9 uu/ml and 206.4 uu/ml.No adverse events were alleged to have occurred with the patient.The e601 analyzer serial number was asked for, but not provided.The customer does not run quality controls daily.
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Calibration signals were within expectations.The last calibration was performed outside of the recommended one month.Control recovery is within specified ranges, but no control data was available from the date of the event.The most likely root cause is that the roche assay does not measure insulin analogues, whereas, cross reactivity to insulin analogues is likely when measured with the abbott architect method.
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