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Intended use: bact/alert® fn plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.Issue description: a notification was received from biofire that they had received a customer complaint from panama of a false positive bcid2 results associated with bact/alert fn plus (plastic) 100 btls -ref.410852, lot 0004061148.Summary: bcid2: serratia marcescens at the time of this assessment there is no indication of the alternate method testing performed to confirm no presence of serratia marcescens.The bact/alert bottle is a qualitative test, detecting the presence or absence of an organism.There is a possibility of the presence of nucleic acids from non-viable microorganisms in the media used in the bact/alert bottles.The presence of nucleic acids from non-viable microorganisms, alone, will not cause the bact/alert bottle to flag as positive for growth as the organism is not viable and cannot grow in the bottle.The physician should use all information available on the patient to interpret the biofire® filmarray® bcid2 panel results accordingly.The presence of contaminating nucleic acid from non-viable microorganisms in the media, not from the patient sample, is a possibility that must be considered when interpreting the biofire® filmarray® bcid2 panel results.
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Context/problem description: one (1) customer notified biomérieux of inoculated bact/alert ®fn plus (part 410852) blood culture bottles having nucleic acid interference with molecular testing.The complaints were associated with clinical false positive results when contents of positive bact/alert bottles were further tested with blood culture identification (bcid) systems, using polymerase chain reaction (copies of organism dna for identification) and there was a detection of serratia marcescens.There was no evidence that the bact/alert system did not perform as intended to detect microbial growth.No harm to patients was reported for any of the complaints associated with this investigation.The instructions for use for the blood culture identification (bcid) products used for testing provided adequate directions for detection of non-viable organisms or nucleic acid levels.These products (e.G., bact/alert bottles, molecular panels) were used in conjunction with other diagnostic test results for the treatment of the patients.Impact: a customer reported nucleic acid interference with biofire bcid2 panel (molecular test) with four (4) bact/alert® fn plus culture bottles, two (2) bottles from lot0004061294 and two (2) bottles from lot 0004061148.The customer could not definitively identify the type of blood culture bottles that were used with positive media and the bcid2 panel testing.The customer provided two bottle ids for each patient, one for fa plus and one for an fn plus bottle.However, the blood culture tests were not impacted.Potential risk for interference with customer use of the bact/alert culture bottles for continuous microbial monitoring in conjunction with bcid2 tests impacts clinical workflow of the laboratory and could have an impact on patient treatment.The impact to patients was not known, the serratia marcescens false positive bcid2 results were reported to the physician for three of the four patients.No specific harm is reported in the complaint record; however, the laboratory does not have access to patient records.It is possible the patients received unneeded antibiotic treatment.The impact to customer is having to perform additional testing (e.G., repeat of the bcid2 test) to identify conflicting organism growth results.This issue of blood culture media may contain non-viable organisms and/or nucleic acid levels that can be detected by the bcid2 panel is discussed in the biofire bcid2 instructions for use.The potential impact to the business is that performing additional testing for confirming positive results increases healthcare costs.No specific impact on business is known but the customer may ask for replacement products at no charge.The risk documents associated with bact/alert plus blood culture products risk were reviewed.Nucleic acid interference with downstream molecular processing/testing pertains to this complaint issue.Overall risk for false positive results associated with this issue is low.Investigation: root cause analysis and conclusion: based on the evaluation of manufacturing, quality control bcid2 panel testing and the information provided by the customer, the root causes for nucleic acid interference with fn plus pertaining to complaint inv-22593: manpower.The customer could not identify whether the blood culture bottles used to collect the patient samples were from an fa plus lot (0004102408) or fn plus lot (0004061294/0004061148) in which media from the bottles was tested with bcid2 panels and resulted in detection for s.Marcescens.The bcid2 panel run files do not have a visual to bact/alert bottle ids; however, durham industrialization was able to identify the bottle ids.Therefore, the two (2) fn plus lots were identified.The customer did not provide any 3d instrument log files around the positive detections related to the bottle ids.If the fn plus bottles were positive, the bottle ids and the instrument log files could have aided in the confirmation.As per the user manual, the 3d instrument has a maximum capacity of holding 1,920 records in the database for retrieval and review.Depending on the workload of the laboratory, the records needed for the fn plus lots could have been deleted and unavailable.Recording of bact/alert bottle details would be a manual task.The filmarray instrument (biofire) does not electronically record any bottle information.The customer¿s inability to provide the more accurate bottle id details in relation to the bottle type used for positive patient samples with the bcid2 panel testing, leaves the fn plus lots involved with nucleic acid interference unconfirmed.Manpower is a contributing factor to this complaint.In addition, subculture results reported by the customer for each of the four (4) bottles were escherichia coli, staphylococcus aureus, staphylococcus hominis (s.Hominis), and staphylococcus epidermidis.All organisms are facultative anaerobes that can grow in an aerobic atmosphere (e.G., fa plus) or an anaerobic atmosphere (e.G., fn plus) except for s.Hominis which can only grow in an aerobic bottle.Therefore, detection of s.Marcescens would have been unlikely in one of the fn plus bottles.Retains: retains from both fn plus lots (0004061294 and 0004061148) were tested with bcid2 panels and results showed no detection of s.Marcescens.Customer testing: the customer tested one (1) uninoculated bottle from fn plus lot 0004061294 and also showed no detection of s.Marcescens.Returned products and testing: returned bottles from the fn plus lots were not required for determining root cause for this investigation.Device history record and complaint trends: the customer communicated two (2) bottle ids (one (1) for an fa plus lot and one (1) for fn plus lots) for each patient sample due to their uncertainty of which bottle type was used for bcid2 panel testing.It was found that two (2) fn plus bottle lots (0004061294 and 0004061148) were represented in the bottle ids list.A sampling of all bact/alert bottle lots are tested with bcid2 panels prior to release of the product to customers.Both fn plus lots resulted in no detection of s.Marcescens during routine qc testing.Queries for manufacturing deviations and complaint records showed no adverse trend for nucleic acid interference.Conclusion: there is no evidence of any bottle malfunction with the bact/alert fn plus culture bottle lots.The bact/alert bottles detected organism growth as intended.Bcid2 testing is being conducted on designated raw materials and samples representing all media bulks for the fill lots for bact/alert products at the durham manufacturing site.Testing of all the media bulks that contribute to the fill lot fills will aid in monitoring product containing nucleic acid residual in an effort to reduce the chances of customers obtaining false positive results with bcid2 panel testing.However, blood culture media may still contain non-viable and/or nucleic acid remnants that can be detected by the biofire bcid2 panel leading to false positive test results, as per the biofire ifu.The customer did not have traceability as to which bottle ids were tested with biofire bcid2 panel.
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Intended use: bact/alert® fn plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.Issue description: a notification was received from biofire that they had received a customer complaint from panama of a false positive bcid2 results associated with bact/alert fn plus (plastic) 100 btls -ref.410852, lot 0004061148.Summary: bcid2: serratia marcescens at the time of this assessment there is no indication of the alternate method testing performed to confirm no presence of serratia marcescens.The bact/alert bottle is a qualitative test, detecting the presence or absence of an organism.There is a possibility of the presence of nucleic acids from non-viable microorganisms in the media used in the bact/alert bottles.The presence of nucleic acids from non-viable microorganisms, alone, will not cause the bact/alert bottle to flag as positive for growth as the organism is not viable and cannot grow in the bottle.The physician should use all information available on the patient to interpret the biofire® filmarray® bcid2 panel results accordingly.The presence of contaminating nucleic acid from non-viable microorganisms in the media, not from the patient sample, is a possibility that must be considered when interpreting the biofire® filmarray® bcid2 panel results.
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