MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® PF PLUS (PLASTIC) - 410853

Catalog Number 410853

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer.

Event Description

A customer in (b)(6) notified biomerieux of a false positive enterobacteriaceae result when testing an infant blood culture sample using the bact/alert® pf plus blood culture bottle (ref.410853, lot 4052717) in conjunction with the biofire® filmarray® instrument.The customer confirmed the patient was an infant with an extensive intra-abdominal surgical history and was known to have esbl colonization.The customer also confirmed the patient had two sets of blood culture testing using lot 4052717.Set one (1) was pulled from a scalp vein and set two (2) was taken from a broviac line culture.The bact/alert® pf plus bottles from both sets flagged positive on the instrument and were then tested on the filmarray(lot 678019).The filmarray results for both sets were enterobacteriaceae and staphylococcus aureus detected.The subculture result for both bact/alert® pf plus bottles grew only staphylococcus aureus.The patient also had a third blood culture tested using a different lot (lot not specified) of bact/alert® pf plus bottles.This bottle also was positive and tested on filmarray(lot 678019).From this blood culture, the filmarray detected only staphylococcus aureus.The customer stated the filmarray result delayed rationalization of broad spectrum antibiotics with prolonged meropenem treatment.The root cause for false positive enterobacteriaceae result obtained by the customer when using the filmarray identification panel is associated with the presence of an increased level of nucleic acid from non-viable enterobacteriaceae and escherichia coli in the biomérieux bact/alert® pf plus bottle.The presence of non-viable organism does not compromise the intended function of the blood culture bottles (culturing viable microorganisms).However, the biofire bcid panel detects nucleic acid from both viable and non-viable organisms.A field safety corrective action was issued by biofire diagnostics on 19-mar-2019 because of an increased rate of false positive enterobacteriaceae and escherichia coli results using the filmarray bcid panel with specific types of biomérieux blood culture bottles.A field safety notice was sent to customers informing about the issue and instructing them to confirm positive results for escherichia coli and enterobacteriaceae by an alternative method prior to reporting the test results.Although there is no indication or report from the laboratory that the discrepant result led to any direct negative impact to the patient's state of health, the customer stated the patient received prolonged meropenem treatment due to the filmarray result delaying rationalization of broad spectrum antibiotics.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

A customer in ireland notified biomerieux of a false positive enterobacteriaceae result when testing an infant blood culture sample using the bact/alert® pf plus blood culture bottle (ref.410853, lot 4052717) in conjunction with the biofire® filmarray® instrument.In response to the customer complaint biomérieux conducted an internal investigation.Evaluation of the reported issue indicated there is no evidence of product malfunction associated with the bact/alert® pf plus blood culture bottle; the bottle flagged positive, as appropriate, for the patient specimen.The investigation concluded that the bact/alert® blood culture bottle is working as intended, and the blood culture results were correct.A trend for complaints related to biofire interference for bact/alert® bottles was identified and a capa investigation was initiated.The capa determined the probable root cause was presence of nucleic acid from non-viable microorganisms from a third party vendor¿s raw materials for the bact/alert® media.Biomérieux is working with the vendor to reduce this issue.The probable root cause of the associated biofire® filmarray® bcid result was the presence of nucleic acid from non-viable microorganisms from a third party vendor's raw materials used in the bact/alert® media.The nucleic acid does not impact the performance of the bact/alert culture bottles or the bact/alert result.Biomérieux is working with the raw material vendor to reduce this possibility of presence of nucleic acid.

• Brand Name: BACT/ALERT® PF PLUS (PLASTIC) - 410853
• Type of Device: BACT/ALERT® PF PLUS (PLASTIC) - 410853
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 9540865
• MDR Text Key: 187517970
• Report Number: 3002769706-2020-00001
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357924
• UDI-Public: 03573026357924
• Combination Product (y/n): N
• PMA/PMN Number: K183166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2019
• Device Catalogue Number: 410853
• Device Lot Number: 4052717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 4292
• Patient Sequence Number: 1