|
An investigation was initiated in response to a customer complaint of obtaining a false positive result while testing blood platelets in association with the bact/alert® bpa culture bottle (ref (b)(4), lot 0001057017).---investigation--- this investigation involved the review of customer contact information with local and global customer service, manufacturing and inspection processes for the bact/alert bpa products, pertinent information from the information for use (ifu) document, and guidance in the bact/alert virtuo instrument manual to reduce the chance of instrument false positive results and evaluation of data acquired from the customer¿s instrument (backup, audit trail of bottle ids, and alarm-alert history files).A root cause analysis and queries for associated complaints pertaining to false positive results with bact/alert culture bottles were also performed as part of this investigation.Complaint trend analysis: queries on complaint data showed no adverse trend is present for the error code c910-false positive-sample related for industry blood culture bottles.No other false positive complaints were received for the bpa lot 0001057017 (expired on 10feb2022).Manufacturing and inspection processes: monitoring and detection methods are inherent to manufacturing processes to identify any bottle defects that could contribute to potential false positive results as a result of the bact/alert culture bottle production.One of the monitoring and methods takes place with the unique device identifier (udi) packaging line with 100% inspection of bottles by civision system and the les inspection system.Another monitoring and detection method is performed during the packaging acceptance quality limit (aql) and final aql visual inspections.A sampling of bottles is inspected as per an aql which is a maximum number of defective units that can be considered acceptable as a process average.Platelet sample composition inoculated into the bpa culture bottle contributed to this complaint issue.The customer did not report any bottle defects prior to using the bpa bottle from lot 0001057017, expiry date 10feb2022.Therefore, a batch review of bpa lot 0001057017 was not required for this investigation.Retains: no requirement for testing of retained culture bottles for bact/alert bpa lot 0001057017.False positive results occurred with inoculated culture bottles.Root cause of the complaint investigation: the fishbone diagram (¿5m+e¿) method of analysis was used to investigate and identify the potential root cause/root cause for this complaint.This cause and effect analysis identifies aspects of the issue in relation to following conditions: measurement, materials, method, machine, manpower, and environment.An analysis was conducted on the instrument data acquired from the customer¿s instrument and communication between customer service/customer pertaining to the false positive that occurred as per this complaint inv-1804.The problem statement was false positive results with bact/alert bpa culture bottles.The is-is not matrix was used to narrow down the factors and verify which ones potentially contribute/contribute to this complaint and those that do not have impact or contribute to this complaint investigation.Based on the evaluation of data and limited information provided by the customer, there are two most probable root causes for the false positive results: materials: bact/alert®bpa culture bottles are designed to be used with bact/alert instrumentation to detect bacteria in platelet components.Bpa culture bottles support the growth of aerobic microorganisms (e.G.Bacteria and fungi).Bpa culture bottles are used in conjunction with bpn culture bottles (supports growth of anaerobic microorganisms to test apheresis platelet samples.The investigator summarized the information from the audit trail and qualtex impacted bottle ids attachment of the two bpa culture bottles drawn from the same donor (e.G.Cell location, time to detection, and final culture results).Two (2) bpa bottles (lot 0001057017) were drawn from the same donor on different dates.One bottle (id patt86dz) was drawn on 28nov2022 and the other bottle (id patt5h3y) was drawn on 25dec2022.The platelet sample composition from the donor is suspect.Bact/alert technology involves the detection of organism growth in nutrient-based media: as the organisms produce co2, the co2 passes through the semipermeable membrane sensor located in the base of the bottle.As the co2 increases, the ph of the media decreases and the sensor becomes yellow, indicating a positive result for growth.The composition of the platelet sample inoculated into the bact/alert bpa culture bottles drawn for the same donor could have had components that simulated organism growth in the bottle, resulting as positive; however, organism growth was not actually present in the bottles.Materials are a contributing factor to this complaint.Manpower: the customer is provided with adequate instructions in the bact/alert virtuo user manual that address how to reduce the chance of obtaining instrument false positive results with bact/alert culture bottles.The troubleshooting section on alarm and alert causes and resolutions provides instruction on how the user can address these visual indicators.A full bottle capacity alarm for a virtuo bank or an alert for a full waste container prevents the automatic unloading of negative bottles from the system.The user needs to perform an operation (e.G.Unload negative bottles, empty waste container) to create open cell locations for new bottles to load into the virtuo bank compartments.The alarm-alert history report from the customer¿s virtuo instrument shows several instances during the test times for the two bpa bottles from the same donor where the user would have had to clear cell locations to allow room for new bottles to load.Unloading of large quantities of bottles could potentially cause a disturbance for the bottles that are still incubating.Unfortunately, the information surrounding the two bpa bottles from the same donor was purged from the virtuo system as it was old data at the time of the backup retrieval.The backup data on these two bpa bottles would have aided in evaluation of the reflectance readings in showing any occurrence of noise (e.G.Dips, waves) in the graphs in relation to the trigger of false positive results.Qualtex laboratories provides patient, donor, and biological testing services.Eligibility criteria for blood donation is based on the fda guidelines.The center for biologics evaluation and research (cber) regulates blood collection to protect patients from unsuitable blood products.An ¿up-front¿ screening of donors and a list of unsuitable donors is required by all blood collection facilities that adhere to the fda guidelines.Donor screening focuses on the medications, travel, health conditions, and lifestyle.Screening forms are dependent on the integrity of the donor¿s answers and the state of health known by the donor at the time of the form submission.In summary, completion of manufacturing activities is required to be appropriately documented and meet good manufacturing practices.The customer is provided with instruction (bact/alert virtuo user manual) for addressing instrument alarm/alerts to reduce the chance of obtaining instrument false positive results.The automated process flow of unloading the bottles from the virtuo instrument is only as efficient as the user¿s attentiveness to addressing instrument signal concerning full bottle capacity situations.Composition of donor samples can be compromised if there is a health issue not known at the time of the donor¿s submission of the screening form.Manpower is a potential contributing factor to this complaint.Conclude product compliance to specification/performance: there is no evidence of any bottle malfunction with the bact/alert bpa culture bottle lots.Monitoring and detection methods for bottle defects associated with potential false positive results are part of the manufacturing and quality control processes for bact/alert culture bottles.False positives are an inherent risk of the culture test as noise in the graph from various sources can trigger a false positive result.False positives can be minimized by following the best practices, see advice below.Advice and recommendations for customer based on ifu/instrument manual/testing: the investigator reviewed the instructions for use [ifu] and bact/alert virtuo user manual which provides adequate directions to reduce the chances of obtaining false positive results with bact/alert bottles: ¿ inspect bottles before use, and do not use any that appear damaged or contaminated ¿ ¿per fda guidelines, each culture bottle must be inoculated with a sample volume of 8-10ml for quality control testing of platelets¿¿ ¿ failure to achieve adequate leukocyte reduction may result in false positive readings ¿ ensure the temperature where the instrument is located fluctuates at a minimum (e.G.Instrument is away from direct vents, window drafts) ¿ the virtuo instrument automatically loads up to 40 bottles that are placed in the loading area at one time.Do not overload the conveyor belt ¿ if bank capacity is full, bottles on the conveyor cannot be loaded into the instrument, user is instructed to unload bottles with final negative or positive status ¿ waste container is nearing capacity, already full, or missing: negative bottles cannot unload from instrument ¿ all instrument positives must be unloaded, and a gram stain and subculture performed.If the gram stain shows no organisms the bottle can be reloaded to complete its incubation time.
|
