The customer contacted a siemens customer care center (ccc).Quality controls (qc) for prothrombin time (pt) were flagged and did not recover in range, but qc for all other assays recovered in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.No optic issues were reported by the cse.The cse found that the sample syringe secure mount was loose.The cse secured the sample syringe.The cse then ran the bcs xp validation kit, which failed the sample wet system validation test.The cse then replaced the sample probe and reran the validation kit, which recovered within specifications.Qc was then run and recovered in range.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, prothrombin time (pt), prothrombin time international normalized ratio (inr), activated partial thromboplastin time (aptt), and d-dimer results were obtained on multiple patient samples on a bcs xp system.Some of the results were flagged with "absorbance too high" and "optical system exceeded the measuring range" errors, but the flagged results were not identified.No discordant results were reported to the physician(s).The delay in patient testing was mitigated as the customer had an alternate bcs xp system to process the samples.There are no reports of patient intervention or adverse health consequences due to the discordant results or the delay in patient testing.
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