The customer stated erroneous patient results were reported out of the lab for ascorbic acid (asa), urobilinogen (uro), and glucose (glu) on the ichem velocity urine chemistry analyzer.The customer stated 25 patient samples reported the same results on (b)(6) 2015.The customer became aware of the event when quality controls failed for asa, uro, and glu.Amended patient reports were sent out 1 day after the incident on (b)(6)2015.There were no reported changes to patient management and no negative feedback was received back from the physician.The customer indicated asa is not reported; lab protocol instructs lab personnel to add a comment to patient records who are also receiving blood work and they test positive for asa.The customer was not able to provide patient data printouts, they were able to give verbal examples of the initial and corrected patient results.
|