Model Number TEST THROMBIN REAGENT |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Siemens is investigating the issue.
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Event Description
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Three falsely depressed thrombin time (tt) results were obtained on a patient sample on two sysmex cs-5100 systems using test thrombin reagent.When the sample was processed initially on the sysmex cs-5100 system (serial number:(b)(6), the sample recovered higher.The initial higher tt result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low tt results.
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2023-00015 on 06-sep-2023.Additional information (08-sep-2023): siemens further evaluated the incident and determined that there was no reagent issue.Quality controls (qc) recovered in range at the time of the event.A repeatability and comparison study was performed between both sysmex cs-5100 systems for thrombin time (tt) and the tt results were comparable on both systems.No further erroneous results have been reported.Preanalytical variables potentially contributed to this event.The investigation findings and investigation conclusion codes in section h6 were updated to reflect the additional information.The reagent is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2023-00013 and 9610806-2023-00014 and the associated supplemental reports were also filed for this event.
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Search Alerts/Recalls
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