The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The bcs xp software appropriately flagged results below the measurement range.Siemens is unable to rule out the effects of pre-analytical variables such as blood sample collection, handling and storage or any patient medication and interferences on the results.Heparin controls in range with both assays, no instrument errors, and no other patients affected indicate that the issue was sample specific.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.
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Discordant, falsely low heparin results were obtained on a patient sample on a bcs xp system using a non-siemens assay.The discordant results were reported to the physician(s).After recalibrating the non-siemens assay, the sample was repeated for heparin on the same bcs xp system using the same non-siemens reagent, resulting higher.This result was reported, as the correct result, to the physician(s).The sample was also repeated one more time on the bcs xp using innovance heparin reagent, resulting higher and confirming the higher result obtained with the non-siemens reagent.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin results.
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