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Intended use; bact/alert® fa plus culture bottles are used with bact/alert® microbial detection systems in qualitative proceduresfor recovery and detection of aerobic and facultative anaerobic (bacteria and yeast) from blood and other normally sterilebody fluids.Description of the issue; a customer in the united states notified biomérieux of obtaining a potential bottle contamination with paecilomyces variotii when using the bact/alert fa plus (plastic) - 410851 (lot#0004101610 - expiration date : 08 march 2024).There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting.Per biomérieux internal standard operating procedures, false positive result in association with bact/alert® fa plus culture bottles is considered to be a potentially reportable event (pre).A false positive result could have a negative influence on the medical diagnosis and potentially on the treatment (e.G.Unnecessary antibiotics, unnecessary diagnostic tests).Mitigated by the fact that other diagnostic information, including clinical findings and laboratory results, are likely available to aid in the medical diagnosis.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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Context: a customer in united states notified biomérieux of obtaining a potential bottle contamination with paecilomyces variotii when using the bact/alert fa plus (plastic) - 410851 ( lot#0004101610 - expiration date : 08 march 2024).Investigation results: information provided by the customer.Unknown sample types: blood and/or body fluids.If blood samples, unknown collection method: venipuncture, syringe, catheter organism identification was performed by maldi-tof (mass spectrometry) organism identified as paecilomyces variotii in at least two (2) fa plus bottles by maldi-tof.Customer was conducting an internal investigation; however, no results were communicated to biomérieux.Complaint analysis: a search againt bottle contamination has been performed and did not indicated any systematic quality issue for the investigated period.The deviation records were reviewed and no record was found to be related to this complaint investigation.Production records: manufacturing directions for bact/alert culture bottles have two process points where bottles are exposed to a high temperature (> 120°c) for a required time period in efforts to reduce the possibility of contaminated units.Exposure of the bottles to the time and temperature of these two process points is sufficient to kill most non-spore forming organisms.In addition, a contamination check on the bottles is conducted by taking a sampling of bottles, prior to the autoclave process (after the bottles have been filled, degassed, stoppered, and capped) and submitted to quality control for bioburden testing.Bioburden determines the number of microbial organisms found in a given amount of material associated with contamination introduced from possible sources (e.G., raw materials, personnel, equipment or cleanliness of the production environment).The bioburden testing of bact/alert production lots aids in the monitoring of any adverse fluctuation that can potentially occur between lots.Bioburden results must pass specifications prior to release of the bact/alert product for use.Monitoring and detection methods are inherent to manufacturing processes to identify any potential contamination of the culture bottles as a result of the bact/alert culture bottle production.Exposure of bact/alert bottles to high temperatures during the manufacturing processes and contamination checks through bioburden testing performed by quality control supports that inoculated bact/alert bottles with contaminating organisms are not due to manufacturing processes.The organism(s) were introduced into the bottle during the sample collection process and/or inoculation in to the bact/alert culture bottles.Users of bact/alert culture bottle are provided with information to reduce potential contamination listed in the information for use (ifu) for all bact/alert culture bottle types.P.Variotii is a spore forming organism; however, these spores are not known to be heat resistant to be able to survive an autoclave cycle.The customer did not report any bottle defects prior to loading the bottles into the virtuo instrument.Deviation/corrective and preventive actions queries were performed and indicate that no systematic quality issue was present during the manufacturing of the product.All quality control specifications passed for release of fa plus products to customers.Retained lot inspection: there were 300 retain samples inspected from lot 0004101610 (expiry date 08mar2024) on 19jul2023 by a gcs investigator.No cloudy bottles (turbid media), or bottles with yellow sensors were found.No other visual defects were evident that would indicate any contamination of these fa plus retain bottles.Root cause analysis: based on the evaluation of data and the information provided by the customer, there are three most probable root causes for contamination source of bact/alert fa plus bottles with p.Variotii : materials, manpower and environment are the potential contributing factors to the root cause of this complaint.Conclusion: there is no evidence of any bottle malfunction with the bact/alert fa plus culture bottle lot.The bact/alert fa plus bottles detected organism growth as intended; however, the organism detected was p.Variotii and a suspected contaminant as per the customer.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert culture bottles prior to the release of product to customers.The optimal growth of p.Variotii, a mold, has been shown at 25°c to above 37°c.However, a study has shown that this mold can survive at least 80°c for 15 minutes.Manufacturing processes for bact/alert culture bottles expose the bottles to higher temperatures than the survival temperature of this organism.There is no indication that the contaminants originated from the manufacturing facility.P.Variotii does form spores, but these spores are not known to be heat resistant to be able to survive an autoclave cycle.There are three most probable root causes for contamination source of bact/alert fa plus bottles with p.Variotii pertaining to complaint (b)(4): materials, manpower and environment are the potential contributing factors to the root cause of this complaint.The investigator reviewed the instructions for use [ifu] and the blood culture booklet.Information from both provide adequate direction to prevent specimen contamination during collection/inoculation into the bact/alert bottles.
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