The customer contacted a siemens customer care center (ccc) and reported that five discordant, falsely low heparin results and one discordant, falsely high heparin result were obtained on six patient samples on a bcs xp system using berichrom heparin reagent.The lab's technical application specialist (tas) reported to siemens that the issue was due to a reagent handling issue.The customer was overdue for a calibration at the time of the event.The customer also leaves the reagent on the analyzer when running quality controls (qc) but places it back in the refrigerator afterward.Per the tas and the customer, the issue was resolved by discussing proper reagent handling.The reagent is performing according to specifications.No further evaluation of this device is required.
|
Five discordant, falsely low heparin results and one discordant, falsely high heparin result were obtained on six patient samples on a bcs xp system using berichrom heparin reagent.The discordant results were reported to the physician(s).Two of the affected patients had their heparin dose increased due to the discordant, falsely low heparin results.The pharmacy later questioned the reported results.The patients were later redrawn and retested for heparin, resulting either higher or lower, respectively.The repeat results were reported, as the correct results, to the physician(s).There are no reports of adverse health consequences for any of the six patients due to the discordant, falsely low heparin results and the discordant, falsely high heparin result.No adverse health consequences were reported for the two patients who received an increase in heparin dose due to the discordant, falsely low heparin results.
|