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 in france notified biomerieux of discrepant results associated with vitek 2 ast-ys08 test kit (reference (b)(4) the customer reported the impacted eeq strain is candida glabrata species and the discrepant result regarding the mic value for voriconazole.While testing this strain on the impacted lot of vitek2 ast-ys08 card, a mic value= 1mg/l, susceptible result instead of resistant as expected for this strain by the survey was obtained.The customer decided to repeat testing on vitek2 ast-ys08 and this time obtained mic value greater than 4mg/l and 8mg/l, resistant.The customer used a can media, the incubation time was 24h, the purity was checked and conformed also the mac farland.The saline solution, quality control and last maintenance were conformed.The internal quality control result conformed and maintenance was complete.The results of this survey for this strain are as follows: (b)(6) of the laboratories obtained a resistant result as expected.No patient outcomes were reported due to the referenced issue as it occurred during an external quality control survey.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated due to a false susceptible voriconazole (vrc), with a candida glabrata abp survey strain involving the vitek® 2 v7.01 ast-ys08 card.Identification of the submitted organism was confirmed and testing included one (1) card from two (2) customer lots (2880454103 called cl1 and 2880555403 called cl2) of vitek 2 ast-ys08 cards, as well as one (1) card from a random lot (2880714103 rl).The reference method, broth microdilution (bmd), was the method used for voriconazole development (formulary vrc01n) on this card: vrc mic = 4 mg/l r.On vitek 2 v7.01 & v8.01 ast-ys08 card: the isolate was subcultured on can 2 medium, under o2 atmosphere.For vitek 2 v7.01: (aes parameters : casfm eucast 2016 + phenotypic) the vrc value (=/> 8 mg/l r) on cl 1 was within essential agreement, within one (1) doubling dilution, compared to the reference mic (bmd - 4 mg/l r) without category error.The vrc value (4 mg/l r) on cl2 and rl was within essential agreement compared to the reference mic (bmd - 4 mg/l r) without category error.The susceptible customer result was not reproduced in-house for vrc on vitek 2 ast-ys08.For vitek 2 v8.01: (aes parameters : casfm eucast 2018_v1 + phenotypic) the vrc values (4mg/l r for cl1 and cl2) were within essential agreement with the reference mic (bmd,4 mg/l r) without category error.The vrc value (=/> 8 mg/l r for rl) was within essential agreement, within one (1) doubling dilution, with the reference mic (bmd,4 mg/l r) without category error.Conclusion: - the susceptible voriconazole customer result was not reproduced in-house on vitek 2 v7.01 and v8.01.- the reference mic equal to 4 mg/l can be s or r within two (2) doubling dilutions.Note: according to the abp report, around 26.8% of biologists who used automated method and eucast/eucast related guidelines, obtained the resistant expected result for voriconazole.A complaint review and analysis was performed.No further action deemed necessary.

• 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: tiffany hall ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 7772832
• MDR Text Key: 117287721
• Report Number: 1950204-2018-00284
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2019
• Device Catalogue Number: 420739
• Device Lot Number: 2880454103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1