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

Catalog Number 414967

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a false susceptible result for a candida glabrata external quality control sample, in association with the vitek® 2 ast-ys07 test kit.The customer twice tested the strain with ast-ys07 and obtained a result of fluconazole susceptible (mic=2) when the expected result was fluconazole resistant (mic=16-32).The strain was cultured on cos (columbia + sheep blood) media for 24 hours at 37°c.The customer reported the incorrect result was not reported to a physician and did not impact a patient results or treatment.The test reports were requested from the customer.A biomerieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was conducted due to a report of false susceptible fluconazole (flu) for candida glabrata lab quality survey sample in association with the vitek® 2 ast-ys07 card.Organism identification was confirmed, and testing included two (2) random lots of vitek® 2 ast-ys07 cards from cba and chrom id candida 2 (can2) subcultures.Note: the customer's lot of ast-ys07 card was expired.Broth microdilution (bmd), the reference method for the fluconazole formulary "flu01n", obtained a result of mic = 4 mg/l (s).Vitek® 2 ast-ys07 obtained fluconazole mic = 2 mg/l (s) from cba subculture, and flu mic = 4 mg/l (s) from can2 subculture, with each random lot tested.The investigation reproduced the customer result.The vitek® 2 results (2 or 4) are in essential agreement, within 1 doubling dilution, with the reference mic (4 mg/l obtained with bmd), without category error.The investigation concluded the vitek® 2 ast-ys07 cards performed as intended.

• Brand Name: VITEK® 2 AST-YS07 TEST KIT
• Type of Device: VITEK® 2 AST-YS07 TEST 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: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6281000
• MDR Text Key: 65914195
• Report Number: 1950204-2017-00033
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133817
• 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: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2017
• Device Catalogue Number: 414967
• Device Lot Number: 287378322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1