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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC. VITEK® 2 AST-N233 TEST KIT; AST-N233 TEST KIT 20 CARDS Back to Search Results
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.
 
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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 Key13590645
MDR Text Key287329338
Report Number1950204-2022-00005
Device Sequence Number1
Product Code LON
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N50510: S103
Number of Events Reported1
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 Date02/15/2023
Device Catalogue Number413117
Device Lot Number6331907103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/05/2022
Initial Date FDA Received02/24/2022
Supplement Dates Manufacturer Received04/14/2022
Supplement Dates FDA Received05/06/2022
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 Number1
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