The investigation determined that higher and lower than expected vitros phenytoin (phyt) results were obtained from samples from three different patients using one lot of vitros phyt slides in combination with a vitros 5600 integrated system.A reagent issue cannot be ruled out as a potential cause.Historical quality controls (qc) for both analyzers shows acceptable accuracy and precision for vitros phyt lot 2617-0170-8772, however a precision run on j56001435 just passed within specifications, and a precision run on j56001428 failed with this lot.A precision run using new vitros phyt lot 2619-0171-0597 was passing on both analyzers, with sdâ¿¿s much lower than the previous lot.This indicates a potential issue with the in-use cartridges of vitros phyt lot 2617-0170-8772 at the time the event occurred, although this cannot be confirmed.Although performance was improved with vitros phyt lot 2619-0171-0597, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt lot 2617-0170-8772.Additionally, the customer is not following the tube manufacturers recommendationâ¿¿s for sample handling.The manufacturer recommends centrifuging samples at = 1300 rcf for 10 minutes in a swinging bucket or 15 minutes for fix-angled centrifuge.The customer is centrifuging for 5 minutes at 2263 rcf.It is likely that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Pre-analytical sample handling cannot be ruled out as a potential cause of these events.
|
A customer obtained higher and lower than expected vitros phenytoin (phyt) results from samples from three different patients using one lot of vitros phyt slides in combination with a vitros 5600 integrated system.Patient 1 result of 30.46 ug/ml versus expected result of 3.20 ug/ml.Patient 2 results of 13.44, 13.24 and 13.57 ug/ml versus expected result of 21.14 ug/ml.Patient 3 results of 16.7 ug/ml versus expected result of 22.59 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.One higher than expected vitros phyt result was reported from the laboratory, but a corrected report was later issued.There was no treatment altered for any of the patients and ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report is number one of five mdr¿s for this event.Five 3500a forms are being submitted for this event as a total of five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).
|