The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The reaction kinetics were correctly evaluated by the system software.No samples from other patients were affected.Differences between the siemens and non-siemens d-dimer methods, such as different sensitivities to hama antibodies, cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00067 was filed for the potentially discordant result obtained on (b)(6) 2020.
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A negative d-dimer result was obtained on a patient sample on a sysmex cs-2500 system using innovance d-dimer reagent.The result was reported to the physician(s).The patient was initially tested for d-dimer in a private laboratory, giving a positive result.The sample was also sent to another laboratory to be tested for d-dimer, also giving a positive result.The positive results were also reported to the physician(s).Five days later, the patient was again tested for d-dimer on a sysmex cs-2500 system using innovance d-dimer reagent, giving a negative result.The sample was then repeated four more times for d-dimer in microsample mode using different dilutions on two different sysmex cs-2500 systems, each time recovering negative.These negative d-dimer results were also reported to the physician(s).It is unknown which d-dimer results were considered correct.There are no reports of patient intervention or adverse health consequences due to the discordant d-dimer results.
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