A customer from (b)(6) notified biomérieux of delayed results when using the vitek® 2 system (ref 27227).Vitek 2 cards were remaining in the preliminary phase with no results being provided.The vitek 2 system was stuck in the initializing process so the instrument was restarted remotely, but the cards that had remained in the preliminary phase were terminated.The cards required repeat testing.There was a power interruption overnight, but the system is plugged into a ups and the hospital's emergency power supply.The customer stated there was a delay in reporting results of greater than 24 hours due to the instrument issue.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
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A customer from (b)(6) notified biomérieux of delayed results when using the vitek® 2 system (ref 27227).The customer indicated that the site had a power interruption overnight after test cards were loaded.The system was connected to a ups and a power conditioner, but it was not confirmed that the vitek 2 was connected to the hospital emergency power.An instrument failure message was observed when the system was rebooted.The customer reported that more than 30 cards remained at the prelim state and later terminated with no results.The requested instrument log files containing the date of the event were not provided.Without the associated instrument and software logs showing detail leading up to the reported event, it is not possible to determine what occurred.The vitek 2 system ups will maintain instrument power for approximately 20 minutes.For power interruptions that exceed this limit, the system will cease reading cards.Following the power failure (unknown duration) and upon successful reboot, it is likely the test cards terminated and ejected due to the time delay between test card readings.This is by design.If test cards are delayed greater than 40 minutes between readings, the test cards will terminate due to insufficient data to provide an accurate result.There is no evidence to suggest the vitek 2 instrument performed outside defined parameters.
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