Model Number BCS XP SYSTEM |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2022 |
Event Type
malfunction
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Event Description
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A discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a bcs xp system.The discordant results were reported to the physician(s).A new sample was drawn from the patient and run for pt and inr, recovering lower.The lower results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant pt and inr results.
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Manufacturer Narrative
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A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse was unable to duplicate the issue and the customer has not observed this issue since it was first reported.The customer believes the issue was caused due to a bad sample draw.Siemens is investigating the issue.
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2022-00046 on 26-aug-2022.Additional information (31-aug-2022): siemens investigation determined that the prothrombin time (pt) measurement curves were evaluated correctly by the bcs xp software.The provided error log file review does not show errors related to the dade innovin reagent, and there were no instrument errors at the time of the event.The siemens customer service engineer (cse) was unable to duplicate the issue and the system is operational.The issue was isolated to the original blood sample collection results and was resolved with a new blood recollection.The customer confirmed that the patient sample was a bad draw.The cause of the event was a pre-analytical issue.The system is performing according to specifications.No further evaluation of this device is required.
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Search Alerts/Recalls
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