MAUDE Adverse Event Report: BIOMÉRIEUX, INC. BACT/ALERT PF PLUS (PLASTIC)

Catalog Number 410853

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: bact/alert® pf plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.Description: a customer in france notified biomérieux of obtaining false positive/contamination results for blood culture samples for one patient in association with the bact/alert® pf plus (plastic) (ref (b)(4), lot 0004100392, expiration date 03-aug-2022).The bottles reportedly recovered stenotrophomonas maltophilia and burkholderia cepacia when these organisms should not have been present.This complaint is related to the complaint (b)(4) (same customer, same issue, different lot).The customer reported that the bottles flagged positive and grew stenotrophomonas maltophilia and burkholderia cepacia.The information provided by the customer indicates that treatment was provided for 24 hours, but after examining the negative cultures, the clinician stopped the treatment.Additional information regarding the type of treatment provided and any negative impact of the treatment has been requested from the customer; the customer has provided no additional information to date.At this time, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation has been initiated to determine the cause for the potential contaminations.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in france that they obtained false positive/contamination results for blood culture samples for four (4) different patients in association with the bact/alert® pf plus (plastic) (ref 410853, lot 0004100350).The bottles reportedly recovered stenotrophomonas maltophilia and burkholderia cepacia when these organisms should not have been present.Investigation: complaint analysis and device history record: review of the complaints database and device history record did not reveal evidence that this issue presents a systemic quality problem.The presence of inoculated bottle contamination was not due to manufacturing processes, or present at the time the bottles were received at the customer's site.Monitoring of environmental parameters occurs for manufacturing rooms and all bact/alert culture bottle release records.There was no evidence in the manufacturing record for the customer¿s bottle lots, other manufacturing data, or complaint data supporting that burkholderia cepacia or stenotrophomonas maltophilia originated from the manufacturing facility.Testing of bottle retains for the two lots reported in the complaint using the molecular test biofire® bcid2 panel, did not identify any microbial dna for the parameters tested for in the bottles.This biofire test panel contains s.Maltophilia but not b.Cepacia.Visual examination of the retained bottles by the investigator observed no evidence of contamination.Publication review: the investigator performed a review of published topics of inoculated blood culture contamination relating to these two organisms.Twelve (12) articles were referenced, and none found that the uninoculated blood culture bottle was the source of the contamination.Burkholderia cepacia and stenotrophomonas maltophilia are aerobic gram negative rods that are known to present in water, and have been reported as contaminants for blood culture as well as nosocomial infections in hospitals.Both organisms can form biofilms.The publications document risk factors for bacteremia with gram negative rods: prolonged hospitalization, prior antimicrobial treatment (carbapenem), icu admission, mechanical ventilator use, indwelling catheter, colonization.The majority of the cases in which bcc bacteria have been detected in clinical samples have an environmental origin, typically from contaminated pharmaceutical/personal care products.Customer data review: evaluation of the customer¿s bact/alert virtuo data backup showed the positive inoculated bottles all had times-to-detection consistent with the organism entering the bottles at the time of the sample.Labeling review: the investigator reviewed the instructions for use [ifu] and determined they provide adequate direction to prevent specimen contamination during collection/inoculation into the bact/alert® bottles.Conclusion: in summary, the bact/alert bottle and instrument performed as designed, by flagging positive indicating growth of an organism recovered on subculture.The bottle did not malfunction and is performing as intended to recovery organisms from the patient's blood.Biomérieux is not aware at this time that the uninoculated bact/alert® bottles are contaminated with any burkholderia cepacia or stenotrophomonas maltophilia, there is no complaint trend to support it, nor any issue in the manufacturing/quality control data.These organisms have not been a source of contamination in biomérieux manufacturing site.

• Brand Name: BACT/ALERT PF PLUS (PLASTIC)
• Type of Device: BACT/ALERT PF PLUS (PLASTIC)
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 100 rodolphe street; durham NC 27712
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: céline strauel ; 5, rue de aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14674181
• MDR Text Key: 301655124
• Report Number: 3002769706-2022-00034
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357924
• UDI-Public: 03573026357924
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Catalogue Number: 410853
• Device Lot Number: 0004100392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1