Model Number PATHROMTIN SL |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer contacted a siemens customer care center (ccc).Quality controls recovered in range at the time of the event.Siemens is investigating the issue.Mdrs 9610806-2021-00007 and 9610806-2021-00009 were filed for the discordant results obtained on (b)(6) 2020 and (b)(6) 2020, respectively.
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Event Description
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Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on four patient samples on a sysmex cs-5100 system and on a non-siemens system, both using pathromtin sl reagent.The discordant results were not reported to the physician(s).The samples were also run for aptt on a bcs xp system using pathromtin sl reagent.The results obtained on the bcs xp systems were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated activated partial thromboplastin time (aptt) results.
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2021-00008 on (b)(6) 2021.Additional information ((b)(6) 2021): section b7 has been updated to indicate that none of the patients were taking anticoagulants.Supplemental mdrs 9610806-2021-00007_s1 and 9610806-2021-00009_s1 were also filed for the additional information obtained on 15-jan-2021.
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2021-00008 on 11-jan-2021.Siemens filed the first supplemental mdr 9610806-2021-00008_s1 on 09-feb-2021.Additional information (08-apr-2021): siemens' investigation determined that the differences in the pathromtin sl results between the sysmex cs-5100 and bcs xp for sample ids (b)(6) and (b)(6) were due to differences in the evaluation algorithm for each system (clot 50% on the sysmex cs-5100 vs.100 mabs threshold on the bcs xp).For sample id (b)(6), in the case of a clot 50 % evaluation on the bcs xp, the coagulation time would be around 39 seconds, compared to 40.3 seconds on the sysmex cs-5100.For sample id 912412454, in the case of a clot 50 % evaluation on the bcs xp, the coagulation time would be around 50 seconds, compared to 50.4 seconds on the sysmex cs-5100.For sample ids (b)(6) and (b)(6), the evaluation on both systems was correct and the reaction kinetics were inconspicuous.The cause of the differences in results for these two samples is unknown.Siemens also identified a bcs xp hardware related issue during backup investigation.The reagent pipettor may cause carry over of multifibren u (thrombin) into the calcium chloride (cacl2) solution of the activated partial thromboplastin time (aptt) test, resulting in shorter aptt results.The reagent pipettor was replaced by a siemens customer service engineer (cse) on 02-mar-2021, after which there were no issues with carryover.The results obtained on the bcs xp for sample ids (b)(6) were still considered to be the correct results for these patients.The reagent is performing according to specifications.No further evaluation of this device is required.Supplemental mdrs 9610806-2021-00007_s2 and 9610806-2021-00009_s2 were also filed for the additional information obtained on 08-apr-2021.
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Search Alerts/Recalls
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