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

Catalog Number 420739

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a false susceptible voriconazole result for a candida glabrata eeq (biologie prospective mycologie 2018-2a) sample when using the vitek® 2 ast-ys08 test kit 20 cards (ref.420739).The strain was a candida glabrata from an (b)(6) patient with esophagitis.The result obtained with the ast-ys08 card was susceptible (mic=1), while the expected result was resistant.The customer performed repeat testing twice with the same lot after receiving the survey results.The results were susceptible (mic=1) and resistant (mic= 4).The customer also tested the strain with another ast-ys08 lot (2880653103) and obtained a resistant result.There was no patient involved as the event involved an external quality control sample.A biomérieux internal investigation will be 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.The customer submitted the isolate for evaluation.Identification of the submitted organism was confirmed and testing included two cards from customer lots (2880600203 called cl1 and 2880653103 called cl2) of ast-ys08 cards, as well as one card from a random lot (2880585403 rl).The reference method used for the development of the incriminated drug was performed in parallel of vitek 2 testing : -broth microdilution (bmd), which was the method used for voriconazole development (vrc01n formulary) : vrc mic = 4 mg/l r, so within two doubling dilutions can be s/i/r.-on vitek 2 v7.01 ast-ys08 card (aes parameters : casfm eucast 2016 + phenotypic) : *on cl1, the vrc value (2 mg/l intermediate) is within essential agreement compared to the reference mic (bmd - 4 mg/l resistant) but lead to a minor error of category.*on cl2, the vrc value (1 mg/l susceptible) is within essential agreement within two (2) doubling dilutions with the reference mic (bmd- 4 mg/l resistant), but lead to a very major error of category.*on rl, the vrc value (>/= 8 mg/l resistant) is within essential agreement within one (1) doubling dilution with the reference mic (bmd- 4 mg/l resistant), without category error.Conclusion : *the false susceptible voriconazole on ast-ys08 card is confirmed in-house only on cl2.Note : the reference mic equal to 4 mg/l can be s, i or r within two (2) doubling dilutions, which can explain the susceptible result.This is a borderline strain.*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; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: debra broyles ; 595 anglum road; st. louis, MO 63042 ; 3147318805
• MDR Report Key: 7675822
• MDR Text Key: 113918896
• Report Number: 1950204-2018-00247
• Device Sequence Number: 1
• Product Code: NGZ
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Catalogue Number: 420739
• Device Lot Number: 2880600203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1