The investigation determined that lower and higher than expected results were obtained from quality control fluids using vitros phyt micro slides on a vitros 5600 integrated system.The most likely assignable cause of the vitros tdm pv iii d5002 results of 35.2, 39.6, >40.0, and >40.0 ug/ml was the calibration associated with the results, as these results were obtained to verify a calibration event.The investigation was unable to identify an assignable cause for the remaining lower than expected tdm pv results that were obtained from a previous calibration.However, there was no evidence that vitros phyt slide lot 2614-0162-7383 or the vitros 5600 system malfunctioned.Historical quality control results obtained using slide lot 2614-0162-7383 were acceptable prior to, and after the event, with no actions taken to mitigate the issue.Finally, a phyt within-run precision test was within acceptable guidelines, indicating vitros slide lot 2614-0162-7383 is performing as intended on the vitros 5600 system.A sample related issue related to the vitros tdm pv fluids in use at the time of the events cannot be ruled out as contributing to the event.The customer was asked if improper pre-analytical sample handling could be the cause of the issue, however, the customer could neither rule out nor confirm if improper sample handling occurred.
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A customer obtained lower and higher than expected results from quality control fluids using vitros phenytoin (phyt) microslides on a vitros 5600 integrated system.Vitros tdm pv i x4558 results of 5.11, 5.26, 5.41 ug/ml vs.The expected result of 7.60 ug/ml.Vitros tdm pv iii d5002 results of 9.61, 13.4 16.7, 35.2, 39.6, >40.0, and >40.0 ug/ml vs.The expected result of 28.70 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.These results were not reported from the laboratory and there was no allegation of patient harm as a result of this event.This report is number 7 of 10 mdr¿s for this event.Ten (10) 3500a forms are being submitted for this event as 10 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).
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