MAUDE Adverse Event Report: BIOMERIEUX INC. AST-N390 TEST KIT 20 CARDS - 423340

Catalog Number 423340

Device Problem Low Test Results (2458)

Patient Problem Sepsis (2067)

Event Date 11/25/2022

Event Type  Injury  

Event Description

Intended use: the vitek® 2 system is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and yeast.The vitek® 2 system is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non-fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms the vitek® 2 gram-negative susceptibility card is intended for use with the vitek® 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram-negative bacilli to antimicrobial agents when used as instructed.Description of the issue: a customer in canada notified biomérieux of obtaining a false susceptible sulfamethoxazole-trimethoprim (sxt) result for salmonella enterica ssp enterica when testing a urinary specimen with the vitek® 2 ast-n390 test kit - reference: 423340 (lot#: 1402120104 - expiration date: 16 sept 2023) in association with the vitek 2 instrument.Patient treatment & condition: the customer indicated that the susceptible sulfamethoxazole-trimethoprim (sxt) result was reported to the doctor and that the patient was treated with sxt.The customer noticed that the sxt-resistant result was incorrect when receiving the analysis from a public health laboratory indicating that the strain was resistant for sxt on november 15th 2022.The customer informed the doctor about the false susceptible result.The doctor indicated that, in the mean time, the patient was admitted to the hospital, and was septic.Once hospitalized, a patient blood sample was tested via vitek 2 giving salmonella : sxt = resistant.The patient started meropenem treatment on (b)(6) 2022.A subsequent urine culture was performed on (b)(6) 2022 with no growth.A repeat blood culture was performed on (b)(6) 2022, and was negative at that time.**summary**: initial testing - vitek 2 / customer site [urinary specimen] sulfamethoxazole-trimethoprim (sxt) - susceptible [on (b)(6) 2022].Alternate method / public health laboratory [urinary specimen] sulfamethoxazole-trimethoprim (sxt) - resistant [on (b)(6) 2022].Repeat testing - vitek 2 / hospital laboratory [blood specimen] sulfamethoxazole-trimethoprim (sxt) - resistant [date not defined].Microbial culture / hospital laboratory [urinary specimen] no growth [on (b)(6) 2022].Blood culture / hospital laboratory [blood specimen] negative [ on (b)(6) 2022].Biomérieux review has determined that this event meets the criteria for reporting as an adverse event.It has been reported by the laboratory that the discrepant result led to the administration of inappropriate treatment and that the patient was subsequently admitted to the hospital.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context a customer in canada notified biomérieux of obtaining a false susceptible sulfamethoxazole-trimethoprim (sxt) result for salmonella spp when testing a urinary specimen with the vitek® 2 susceptibility card - ast-n390 test kit - reference 423340 (lot# 1402120104 - expiration date: 16 sept 2023) in association with the vitek 2 instrument.Patient treatment & condition the customer indicated that the susceptible sulfamethoxazole-trimethoprim (sxt) result was reported to the doctor and that the patient was treated with sxt.The customer noticed that the sxt-resistant result was incorrect when receiving the analysis from a public health laboratory indicating that the strain was resistant for sxt on (b)(6) 2022.The customer informed the doctor about the false susceptible result.The doctor indicated that, in the mean time, the patient was admitted to the hospital, and was septic.Once hospitalized, a patient blood sample was tested with a vitek 2 instrument giving salmonella : sxt = resistant.The patient started meropenem treatment on (b)(6) 2022.A urine culture was performed on (b)(6) 2022 with no growth.A repeat blood culture was performed on (b)(6) 2022, and was negative at that time.Investigation results complaint analysis a complaint analysis against ast-n390 card lots #1402120104 (customer lot) and lot #1402202104 (random lot used for the in site testing) has been performed.This review did not indicate any systematic quality issue related to the indicated card lots.A complaint analysis for false susceptible sxt complaints when testing salmonella did not indicate any systematic quality issue.No corrective and preventive action has been opened for this performance issue during the investigated time frame.Analysis of production record ast-gn390 lots met final quality control release criteria.The lots passed quality control performance testing.No non conformities were written against the lots.No non conformities were written for the ast-n390 cards for performance issues related to this investigation during the investigated period.Analysis of strain submitted/ retained lot testing the customer's submitted strain was subcultured to tsab agar and incubated at 35-37 degrees c.A second subculture was performed, identification confirmed using the gn card as salmonella group, and testing included ast-n390 cards from the customer's lot (1402120104) and a random lot (1402202104) as well as broth microdilution (bmd) as the reference method used in development of sxt02n drug version found in this card.In site, six (6) ast-n390 cards from the customer lot and (6) six cards from the random lot were tested.For 10 of 12 of these cards, the sxt terminated with the analysis message ¿insufficient growth in positive control well".The 2 sxt results that didn¿t terminate were on cards from the random lot.The customer¿s false susceptible result is being partially duplicated with multiple terminations also occurring on both the tested lots and showing an essential agreement and a very major category error for the vitek 2 for this strain.Analysis of the internal testing data the graphs from both customer lot and random lot show similar growth patterns for this strain.The pc wells and drug wells are either coming up very late or barely growing.Overall, this is a strain issue.It grows very weakly in the vitek 2 environment.To be noted that the local customer service confirmed with the customer that the correct strain was submitted.Another repeat test has been requested at the customer's site, resulting in one termination, and a sxt mic = 40.Analysis of the laboratory reports a review of the customer's submitted laboratory reports showed only terminations of piperacillin/ tazobactam for both the urine and blood culture isolates.Conclusion this investigation indicates an unusual growth of one strain causing several termination card issue with the vitek 2 system.Because of the poor growth of the strain in the vitek 2 card, it has been not possible to investigate further the strain.No implication of systemic quality issue for salmonella group and trimethoprim/sulfamethoxazole (sxt02n) has been identified.

• Brand Name: AST-N390 TEST KIT 20 CARDS - 423340
• Type of Device: AST-N390 TEST KIT 20 CARDS - 423340
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: pauline prévitali ; 5 rue des aqueducs; craponne
• MDR Report Key: 15914385
• MDR Text Key: 304792963
• Report Number: 1950204-2022-00049
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073406
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2023
• Device Catalogue Number: 423340
• Device Lot Number: 1402120104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Date Device Manufactured: 03/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention