The customer contacted siemens customer care center (ccc) to report that discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system.Siemens reviewed the instrument backup files and determined that quality controls (qcs) were within the expected specifications.Siemens identified that maintenance was performed regularly on the system and all inspected kinetics were evaluated correctly by the system software.The cause of the discordant, falsely elevated aptt result is patient's possible medical condition.The instrument is performing according to specifications.No further evaluation of the device is required.Mdr 9610806-2018-00108 was filed for the same event which occurred on (b)(6) 2018.Mdr 9610806-2018-00109 was filed for the same event which occurred on (b)(6) 2018.Mdr 9610806-2018-00110 was filed for the same event which occurred on (b)(6) 2018.
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Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system.The initial discordant result was reported to the physician(s), who questioned the result.Multiple samples from one patient were repeated on the same system, resulting falsely high.The patient was re-drawn and the new sample was run on a non-siemens instrument, resulting lower.The result obtained using the non-siemens methodology was reported, as the correct result to the physician(s).The patient's scheduled arthroscopic surgery was delayed due to the pathological, falsely elevated aptt results and further testing was required.The patient tested negative for factor and lupus anti-coagulants.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt result.
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