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| Catalog Number 411660 |
| Device Problem
Device-Device Incompatibility (2919)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Intended use bact/alert® virtuo® microbial detection system is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids and from blood platelet samples.In blood bank facilities, the bact/alert® virtuo® microbial detection system will provide in-process testing for the presence or absence of microorganisms.Description of the issue a customer in the united kingdom notified biomérieux of obtaining a delayed result when using the virtuo, a unit - reference 411660 (serial number (b)(6).The customer notified that he has two virtuo instruments : a virtuo at luton and a virtuo at bedford.It is understood that positive bottle results from luton have not been received to the laboratory information system (lis) at bedford where the bottles are further tested.The customer indicated that the gram staining has not been performed for these bottles because bedford site has not received these bottles.Therefore, for now, it is not possible to know whether or not these bottles were a true positive, or a false positive.At the time of the assessment, the customer does not know what happened to these bottles, whether they remained on the instrument or not.Information from winpath (not a biomérieux product) indicates discrepant results for the bottles.The initial result indicates "growth detected" while a "no grow after 5 days incubation" has then been sent from the virtuo on different dates.Biomerieux has been informed that this incident did not cause any patient death or harm.The two impacted patients have been discharged.This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting.Per biomérieux internal standard operating procedures, delayed result> 8 hours in association with virtuo instrument are considered to be potentially reportable events as a delay may exist in the therapy being initiated or tailored appropriately.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomérieux internal investigation will be initiated.
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Manufacturer Narrative
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Context: a customer in the united kingdom notified biomérieux of obtaining a delayed result when using the virtuo, a unit - reference (b)(4) (serial number#(b)(6)).Investigation results: review of the extracted data: reviewing the extracted data shows that luton site sends positive bottles to bedford site for work up.Bedford site was going through incomplete reports from winpath (customer's laboratory information system [lis]) and positives from (b)(6) 2024 seem to have not been received by bedford.Also, some seemed to flag positive and then later called negative (in winpath).Root cause analysis: the root cause analysis could not determine a definitive root cause.However, possible contributors to the two positive results not transmitting to the customer¿s laboratory information system (lis) clinisys winpath are listed below: bci or the customer's lis may be a probable root cause.The bci log files were reviewed, and it was determined the instrument sent the positive messages to bci and no lis related alarms are found related to the time these bottles were loaded and incubating.The customer did not provide their lis system¿s trace logs to determine the communication between bci and the customer¿s lis.The user is another probable root cause.The user did not follow the bottle ifu by performing a gram stain and subculturing the positive bottles, the user did not print a daily positive report and the user¿s workflow seems confusing.The user mishandled the bottles, specifically when unloading positive bottles because their system was configured for the user to request to unload positive bottles.The bact/alert® sa culture bottle ifu (document 043259- 01 - 2020-10), bact/alert® virtuo® system user manual - rel 3.1 (document 050574-02 - en) and user manual myla clinical use (document 4501-2126 - e - en - na) were reviewed by the investigator and provide adequate directions for the user in handling positive bottles.Device history record and complaint trends: queries of manufacturing data and review of manufacturing records for the bact/alert® virtuo® instrument did not reveal any systematic quality issue related to lis/bci interface.Product compliance to its specification/ performance: no malfunction of the bact/alert® virtuo® system was revealed by this investigation.Analysis of the customer configuration: the bact/alert® virtuo® software is designed to send bottle results to the lis as configured per the user¿s desired behavior for each of the three types of results ¿ positive, negative, and negative to date.The customer has configured the bact/alert® virtuo® instrument to follow the astm communication protocol by sending test orders between myla and the lis, upload all bottles with a final status (positive or negative) to their lis, lis negative to date message sending at 36 hours of incubation and the final result.The lis consolidated messages feature is disabled.Also, the customer configured the bact/alert® virtuo® software for the user to request to unload positive bottles, negative bottles are automatically unloaded and there is no login required to unload bottles.The customer chose to use the following lis mapping codes for the lis to interpret results as follows: ¿pos¿ to indicate positive bottle result, ¿neg¿ to indicate a negative bottle result, and ¿unk¿ to indicate a negative to date bottle result.The lis mapping codes are used by the customer/lis vendor to easily view the blood culture result in a transmission session and patient record.The bact/alert® virtuo® instrument uses bci connect software for session transmission, for example a session is sent to the lis because the bottle¿s result changed.In this case, the messages for the positive bottles were received by bci connect from the bact/alert® virtuo® instrument.Positive results go to the lis as a preliminary result because they must be confirmed with a gram stain and subculture.If a gram stain shows no organisms are present the bottle is reloaded on the instrument per the culture bottle instructions for use (ifu) and the result automatically reverts to negative to date.Negative results go to the lis as a preliminary when they flag at the configured maximum test time.Then when the bottle is unloaded, the results go to the lis again as a final negative.When the lis interface communication is not working, the virtuo/myla will alert with a loss of communication message.It is recommended the user to follow the on screen prompts to troubleshoot the issue.It is not known why the customer did not reload the positive bottles (bottle ids: (b)(6)) or perform a gram stain and subculture.The (b)(6) bottle graphs visually look positive; they both show a positive curve.The data provided supports that the bact/alert® virtuo® instrument performed as designed to update the bottle results, sent the result status to bci, and no malfunction is found.There seems to be confusion with the customer around the customer¿s workflow of handling positive bottles.Mishandling the bottles, specifically unloading two positive bottles have caused incomplete work lists which led to a delay in reporting the two patient results.Conclusion: the investigation did not indicate any systematic quality issue related to this complaint.The most probable root causes are related to the lis used by the customer or potential user mishandling of the bottles.Recommendation has been given to the customer on how to properly handle a positive bottle.
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