This report is being submitted due to a retrospective review conducted under capa-(b)(6).There is no documentation of when the fse visited the customer site.The complaint indicates that the fse tried different reagents to rule out reagent contamination unsuccessfully.The ticket indicates that after decontaminating system the variant peak disappeared and now reporting and operating properly with good control values.No additional information was provided.A review of complaint history for the next four (4) months the after this ticket was opened did not identify any further assistance requested by the customer, therefore, no further action required by field service.The most probable cause of the reported event was due biological contamination of system.
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On (b)(6) 2016, a customer contacted the distribution center due to obtaining peaks of unknown origin,- hb-var detect alarms and it was detecting an h-v1 peak in all samples processed.The customer was unable to run hba1c patient samples.A field service engineer (fse) from a distributor was dispatched to address the reported event, which resulted in delayed reporting of hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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