Siemens has completed its investigation of the alleged issue and concluded the following: an assessment of the data provided by the customer suggests the presence of a sample interferent (medication, a quaternary ammonium compound such as benzalkonium chloride or sample contamination).This is believed to be the underlying cause of the observed sample delivery failures and iqc errors.Results from a test of retained cards (lot 01-19291-20) performed acceptably during in-house testing and no sample delivery errors or iqc failures (internal error codes) were observed.Additionally, a review of the in-house performance of the card lot in use did not identify any trends or product deficiencies.The conclusion from the complaint investigation indicates that the system and reagent cards performed as intended.Based on the complaint and available information, the customer is not alleging that a delay in obtaining sample results or that the use of the device caused or contributed to the patient's death.The customer stated the qc was in the expected ranges at the time of the event.The customer did not provide information regarding age, pre-existing conditions, medications and the date and cause of death.This mdr is being filed out of an abundance of caution due to the information from the customer stating that the patient is deceased.
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