MAUDE Adverse Event Report: BIOMÉRIEUX, INC. AST-N368 TEST KIT 20 CARDS

Model Number 421855

Device Problem Low Test Results (2458)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Event Description

Intended use: 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.Issue description: a customer in (b)(6) notified biomérieux of a false susceptible meropenem result for aeromonas hydrophila in association with a vitek 2 gram-negative ast test kit (reference and lot number (not provided).The customer obtained a susceptible meropenem result and prescribed meropenem to the patient.Additional testing via colorimetric blue-carba assay showed the presence of a carbapenemase enzyme, so meropenem was discontinued, and treatment was changed to trimethoprim-sulfamethoxazole.The patient was treated for 21 days, with a favorable course and no sequelae.

Event Description

Intended use: 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.Issue description: a customer in argentina notified biomérieux of a false susceptible meropenem result for aeromonas hydrophila in association with a vitek 2 ast-n368test kit (reference and lot number (not provided).The customer obtained a susceptible meropenem result and prescribed meropenem to the patient.Additional testing via colorimetric blue-carba assay showed the presence of a carbapenemase enzyme, so meropenem was discontinued, and treatment was changed to trimethoprim-sulfamethoxazole.The patient was treated for 21 days, with a favorable course and no sequelae.

Manufacturer Narrative

An internal complaint was initiated regarding a journal article "meningitis due to carbapenemase-producing aeromonas hydrophila: a case report" from argentina.The article describes a false susceptible meropenem result for aeromonas hydrophila in association with a vitek 2 gram-negative ast test kit (reference and lot number (not provided).The customer obtained a susceptible meropenem result and prescribed meropenem to the patient.Additional testing via colorimetric blue-carba assay showed the presence of a carbapenemase enzyme, so meropenem was discontinued, and treatment was changed to trimethoprim-sulfamethoxazole.The patient was treated for 21 days, with a favorable course.No response received from lcs regarding strain submittal or additional product information.R&d review: 1) nature of the event and impact: susceptibility testing was performed using vitek 2 and diffusion method on an isolate of aeromonas hydrophilia from the spinal fluid of a 6-year old female.The isolate tested sensitive to carbapenems on both vitek 2 and diffusion method (exact type of diffusion method tested was not described).The isolate also underwent rapid colorimetric testing (blue-carba)which was positive for the presence of a carbapenamase.The article claims false susceptibility to carbapenems by vitek 2 and therefore this is a pre according to current procedures.2) respect for instructions for use of the product: no evidence against.The article did not say what vitek 2 card type or version of antimicrobial test were used in the study.It did state the following drugs tested as sensitive; trimethoprim-sulfamethoxazole, ciprofloxacin, cefotaxime and meropenem.It is unclear if other carbapenems were on the card that did test resistant.3) relevance of the methodology: vitek 2 sensitive results were compared to blue-carba, a rapid colorimetric test for detection of carbapenamases.The reference method for vitek 2 ast testing is broth microdilution or agar dilution.4) observed study results compared to claimed product performance: there was only one isolate tested and in addition reference testing was not performed.It is therefore not possible to compare to published performance.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.The lot numbers for the implicated cards are not available, so qc performance review of the lots cannot be performed.

• Brand Name: AST-N368 TEST KIT 20 CARDS
• Type of Device: AST-N368 TEST KIT 20 CARDS
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15829338
• MDR Text Key: 303989815
• Report Number: 1950204-2022-00046
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K201675
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421855
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• 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