The customer contacted a siemens customer care center (ccc).Quality controls (qc) for the negative qc recovered low and out of range at the time of the event.The positive qc recovered in range, but borderline low.A siemens customer service engineer (cse) was dispatched to the customer site.The cse observed that the customer accidentally placed calcium chloride (cacl) in position 1 on the bcs xp system, instead of washing solution.The cse discarded the cacl bottles on the system.The cse placed a new cacl bottle on the system and placed new washing solution in position 1.Three pipettor washes were performed, after which qc was repeated, recovering in range.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2021-00044 was filed for the discordant aptt results obtained on (b)(6) 2021 on the same bcs xp system.
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Discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on a patient sample on a bcs xp system using pathromtin sl reagent.The discordant results were reported to the physician(s).It is unknown what the correct aptt result is for this patient.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low activated partial thromboplastin time (aptt) results.
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