MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 AST-YS09 TEST KIT

Catalog Number	423331
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Intended use: the vitek® 2 fungal 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 yeasts to antifungal agents when used as instructed.Description: a customer in the united states notified biomérieux of obtaining a false susceptible fluconazole result for candida albicans while analyzing a patient sample with the vitek® 2 ast-ys09 test kit (ref (b)(4), lot 2892048203).The customer reported that they obtained a fluconazole susceptible result with the vitek 2 ast-ys09 test kit.The patient was treated with fluconazole for two weeks based on the susceptible result.After two weeks, the patient was not improving, so the treating physician requested that the isolate be sent to a reference laboratory for additional testing.The reference laboratory obtained fluconazole resistant results.The customer then also tested the isolate with a fluconazole etest® strip and obtained resistant results.Treatment was changed from fluconazole to a different drug after the resistant results were reported.Initial vitek 2: fluconazole mic <= 0.5 mg/l (susceptible).Repeat vitek 2: fluconazole mic = 1 mg/l (susceptible).Reference laboratory: fluconazole mic > 256 mg/l (resistant).Etest: fluconazole mic > 256 mg/l (resistant).The patient was provided treatment with fluconazole for two weeks based on the vitek 2 results that were provided to the treating physician.Treatment was changed after corrected test results were provided to the treating physician.There is no indication or report from the customer that the patient's condition worsened due to the initial treatment that was provided.An investigation has been initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of obtaining a false susceptible fluconazole result for candida albicans while analyzing a patient sample with the vitek® 2 ast-ys09 test kit (ref (b)(4), lot 2892048203).---investigation--- complaint trend analysis: global customer service (gcs) performed a complaint trend analysis.Complaint history review was completed for this issue during the last 13 month time frame with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.Investigational testing: the customer's isolate was received and sub-cultured to sabouraud dextrose agar (emmons) and incubated at 35 to 37°c aerobic, in non-co2 atmosphere for 24 hours.The isolate's identification was confirmed to be candida albicans via vitek ms testing.A second subculture was performed and testing from the customer's lot (cl, 2892048203) and a random lot (rl, 2892168203) was performed in duplicate.Additionally, broth micro dilution (bmd) was performed as a reference method.For all four (4) cards tested (clx2, rlx2), a susceptible flu mic of 1 was obtained while bmd testing resulted in a resistant mic of > 128.Review of card data showed that growth was slightly delayed in the card leading to the flu mic call of 1.Manufacturing record review: ast-ys09, lot 2892048203 (cl) and lot 2892168203 (rl) met final qc release criteria.The lots passed qc performance testing.No non-conformances were written against the lots in question.Non-conformances were reviewed for the last 13 months ((b)(6) 2021 to (b)(6) 2022).No non-conformances were written against the ast-ys09 cards for performance issues related to this investigation.---conclusion--- the customer's false susceptible result was duplicated resulting in both an essential and very major category agreement error for both lots tested due to slightly delayed growth in the cards.The isolate will be added to the r&d stock collection.There is no implication of a systemic quality issue related to fluconazole or the lots in question.

• Brand Name: VITEK® 2 AST-YS09 TEST KIT
• Common Device Name: VITEK® 2 AST-YS09 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15555763
• Report Number: 1950204-2022-00027
• Device Sequence Number: 6584737
• Product Code: NGZ
• UDI-Device Identifier: 03573026619268
• UDI-Public: 03573026619268
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2023
• Device Catalogue Number: 423331
• Device Lot Number: 2892048203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown