MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-YS08 TEST KIT

Catalog Number 420739

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of false susceptible voriconazole results when testing a candida glabrata biologie prospective survey strain (myco 2018-2a) with the vitek® 2 ast-ys08 test kit, lot 2880585403.The customer obtained the following results: voriconazole susceptible (mic = 1) two times and intermediate (mic = 2) one time.The customer retested the strain using a different lot of the vitek 2 ys08 cards and obtained a resistant result (mic = 4).The expected result for this strain is resistant.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This investigation was initiated due to a customer reporting a false susceptible voriconazole (vrc) result with candida glabrata bp survey strain (myco 2018-2a) on vitek® 2 v7.01 ast-ys08 card.Identification of the submitted organism was confirmed and testing included one card from the customer lot (2880585403 cl) of ast-ys08 cards, as well as one card from a random lot (2880600203 rl).The reference method broth microdilution (bmd), used for the development of the incriminated drug (vrc01n formulary), was performed in parallel of vitek 2 testing: vrc mic = 4 mg/l resistant.On vitek 2 v7.01 ast-ys08 card (aes parameters : casfm eucast 2016 + phenotypic) : the vrc values (4 and >/= 8 mg/l) are within essential agreement (within 1 doubling dilution for the value at >/= 8) compared to the reference mic (bmd - 4 mg/l resistant), without category error.Susceptible customer results are not reproduced in-house on both lots tested.The vitek 2 ast-ys08 cards performed as intended and no further action is required.

• Brand Name: VITEK® 2 AST-YS08 TEST KIT
• Type of Device: VITEK® 2 AST-YS08 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: candace martin ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 7654630
• MDR Text Key: 113394829
• Report Number: 1950204-2018-00241
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2019
• Device Catalogue Number: 420739
• Device Lot Number: 2880585403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1