Intended use: the vitek® 2 instrument is intended for the automated quantitive and qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and clinically significant yeast.The vitek® 2 instrument is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non-fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Description of the issue: a customer in the united states notified biomérieux on 29-apr-2021 of a delay in reporting patient results in association with the vitek® 2 v8.01 hp rp5810 pc (ref.421648, s/n (b)(4)).The customer stated that patient test results were not being displayed in the vitek 2 software application.In addition, the system is experiencing "internal system errors".Local customer service (lcs) accessed the system remotely via securelink, and identified a "setup tech list error" followed by "internal system errors" at 9:02am on (b)(6) 2021.The most recent isolates listed in the view and maintain isolate review screen were from sunday, (b)(6) 2021.Lcs assisted the customer with a data restore from (b)(6) 2021.In addition, a batch file was executed to correct the setup tech list errors.Both actions were successful, and the pc rebooted to a functional state.Due to the internal system errors, there was a delay in reporting patient results following re-testing.The number of patients whose results were delayed was not disclosed by the customer.There is no indication or report from the customer that the delayed results led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
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On (b)(6) 2021, a customer in the united states reported that vitek® 2 results did not appear in the cassette list when using the vitek 2 instrument (ref.(b)(4)) ¿ serial number (b)(6).The customer reported the issue was observed when placing samples into the vitek 2 instrument, and the samples do not appear in the vitek 2 systems software version (8.01) on the next day.Customers whose systems exhibit the inability to access the vitek 2 systems web client caused by an invalid certificate should run the certificate scripts in vitek® 2 systems software to resolve the condition.Biomérieux global customer service (gcs) notification mar 4277, issued (b)(6) 2019, includes steps to prevent this issue and includes necessary steps to resolve the invalid https certificates if encountered.This anomaly is resolved in vitek® 2 systems software versions 9.01.1 and 9.02.Biomérieux recommends for customers to consider upgrading to vitek® 2 systems software versions 9.01.1 or 9.02 to prevent the loss of card data and future occurrences of this anomaly.Additionally, a software maintenance release was launched on (b)(6) 2021 to address this issue.
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