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

Catalog Number 414967

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a false susceptible fluconazole result for a candida albicans strain from a patient blood culture sample, in association with the vitek® 2 ast-ys07 test kit.The customer reported the initial fluconazole result with the ast-ys07 card was susceptible (mic =4 mg/l).The strain was sent to a reference lab and the result was resistant (mic>= 64¿g/ml) for fluconazole.There was no retest performed on the ast-ys07 card.The customer stated the false susceptible result was reported to the physician, was then corrected following lab reports from the reference lab.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) had reported to biomérieux a false susceptible fluconazole result for a candida albicans strain in association with the vitek® 2 ast-ys07 test kit.The customer reported the initial fluconazole result with the ast-ys07 card was susceptible (mic =4 mg/l).The strain was sent to a reference lab, and the result was resistant (mic>= 64 g/ml) for fluconazole.There was no retest performed on the ast-ys07 card.An internal biomérieux investigation was performed using the isolate submitted by the customer.This investigation was initiated due to discrepant fluconazole (flu) results for candida albicans in association with vitek® 2 ast-ys07 and ast-ys08 cards.For the vitek 2 ast ys07 test kit (the subject of this report), investigational testing included: - identification of the isolate was confirmed as candida albicans.- broth microdilution (bmd), the reference method used for the development of fluconazole, obtained a flu result mic

• Brand Name: VITEK® 2 AST-YS07 TEST KIT
• Type of Device: VITEK® 2 AST-YS07 TEST KIT
• 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: 7096329
• MDR Text Key: 95764192
• Report Number: 1950204-2017-00435
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2018
• Device Catalogue Number: 414967
• Device Lot Number: 2870283203
• Other Device ID Number: 03573026426873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1