MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-N233 TEST KIT; AST-N233 TEST KIT 20 CARDS

Catalog Number 413117

Device Problem Missing Test Results (3267)

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

Event Type  malfunction  

Event Description

Issue description: a customer in (b)(6) notified biomérieux of obtaining delayed results >24 hours in association with the vitek 2 ast-n233 test kit (ref.413117, lot 6331907103, expiration date 15-feb-2022).It is understood that the customer obtained discrepant susceptibility results for proteus vulgaris between vitek 2 ast-n233 and disk diffusion method.It was reported that vitek 2 didn¿t identify esbl (extended spectrum beta-lactamases) phenotype.According to biomérieux global customer service, the media initially used by the customer (pvx) was not an acceptable media for use with gn ast testing.It was reported that the customer has repeated the test with another media (trypticase soy blood agar) and that results were the same.In this context, the results were delayed >24 hours to communicate esbl results to the clinician.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.An investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer in france that they obtained results delayed > 24 hours while using the product ast-n233 test kit 20 cards (ref.413117, lot 6331907103, expiration date 15-feb-2022).Investigation: batch history record and complaint analysis.There is no capa related to the customer¿s complaint recorded.The complaint analysis did not reveal this issue as a systemic quality problem.Investigation results.The submitted customer strain was subcultured on tsab (tss bmx) medium for vitek 2 testing and cba (cos bmx) medium for diffusion testing under aerobic atmosphere.The identification was checked on vitek 2 gn card (lot: 2411807103) and a low discrimination between proteus penneri / proteus hauseri was obtained.Then, to solve this low discrimination, the strain was tested with vitek ms v3 (knowledge base v3.2) and a low discrimination between proteus vulgaris 50% / proteus penneri 50% was obtained.The strain was then sequenced (whole genome sequencing (wgs)) and it confirms that the strain is not a proteus vulgaris nor a proteus penneri nor a proteus hauseri.- with the analysis of the complete genome, the closest genome belong to a proteus columbae.- with the full-16s gene, the best similarity is with a proteus alimentorum.But the identification to those species cannot be formally confirmed which classify this isolate among the atypical strains.Nevertheless, p.Columbae and p.Alimentorum are the closest species and they do not belong to vitek 2 and vitek ms knowledge bases.The vitek 2 reproducibility testing on the incriminated lot and on the random lot were then not analyzed since those species are not present in the vitek 2 knowledge bases.The esbl phenotype of the strain was nevertheless checked.The strain was sequenced to determine the expected phenotype (whole genome sequencing (wgs)).Gene cuma-huga like was identified confirming that this strain is a wild cefuroximase.No gene encoding an extended spectrum beta-lactamase was detected on this strain.The presence of an esbl was also checked phenotypically with the esbl screening test using key hole test and it gave a negative result (absence of synergy), confirming the strain is not an esbl bacteria.Conclusion: - the proteus vulgaris identification obtained by the customer is not confirmed in-house.- the sequencing of the strain shows that it does not belong to vitek 2 and vitek ms knowledge bases.It is therefore not possible to give ast vitek 2 results on this strain.- the wgs result also confirms that this strain is a wild cefuroximase and not an extended spectrum beta-lactamase producing bacteria.- ast-n233, lot 6331907103 met final qc release criteria.The lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-N233 TEST KIT
• Type of Device: AST-N233 TEST KIT 20 CARDS
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13590645
• MDR Text Key: 287329338
• Report Number: 1950204-2022-00005
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N50510: S103
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2023
• Device Catalogue Number: 413117
• Device Lot Number: 6331907103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1