MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 YEAST ANTIMICROBIAL SUSCEPTIBILITY TEST AST-YS07 TEST KIT; VITEK® 2 AST-YS07 CARD

Catalog Number 414967

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) notified biomerieux of discrepant results associated with vitek 2 ast-ys07 test kit involving voriconazole for one isolate, candida albicans, from an external quality control neqas sample (distribution 3789 - strain 2983).(b)(4) expected voriconazole resistant ( mic >8 mg/l r-) but the customer obtained voriconazole sensitive (<=0.12).Customer results from columbia blood agar were voriconazole mic <=0.125 mg/l s (twice).There was no patient injury or any adverse event associated with this issue.An internal biomerieux investigation was conducted.Broth microdilution (the reference method for voriconazole development) was performed to determine the intended result, compared with ast-ys07 cards.Two (2) different lots of ast-ys07 cards from sda and cos bmx media.Broth microdilution provided a voriconazole mic >16 mg/l r.On vitek 2, biomerieux obtained results as follows: from sda media and on two (2) ast-ys07 lots: voriconazole mic = 1 s.From cos media and on one (1) ast-ys07 lot: voriconazole mic <=0.125 s.Vitek 2 voriconazole results (<=0.125 - 1 mg/l s) are essential agreement errors (gap >2 doubling dilutions with the reference mic).Biomerieux duplicated the customer's results.Complaint history was reviewed with no trends noted.The investigation concluded the discrepancy involved an atypical strain.In addition, in the final report from (b)(4), voriconazole was not graded since the level of concordance voriconazole (59%) did not reach the requisite 80% of participants.

• Brand Name: VITEK® 2 YEAST ANTIMICROBIAL SUSCEPTIBILITY TEST AST-YS07 TEST KIT
• Type of Device: VITEK® 2 AST-YS07 CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5620602
• MDR Text Key: 44129435
• Report Number: 1950204-2016-00051
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2017
• Device Catalogue Number: 414967
• Device Lot Number: 287368220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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