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

Catalog Number 414967

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of a discrepant result with the vitek 2 ast-ys07 (reference 414967).The customer reports using a yst card in which the organism, c.Parapsilosis, was identified; however, when performing the antibiotic susceptibility test a discrepancy occurred with the drug fluconazole.Based on the information provided, there was no adverse events, negative patient impact or delay in results.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A biomerieux internal investigation was conducted for a false susceptible fluconazole result on the vitek® 2 ast-ys07 card for an external quality control isolate, candida orthopsilosis, which is not a claimed species for the vitek® 2.The external quality control report stated the intended result for fluconazole was resistant, and the fluconazole alternate testing results using the biomerieux etest® method were: -lab 1: mic =1,5 mg/l presence of macro colonies which may indicate hetero-resistance.-lab 2: mic =12mg/l resistant.The reference bmd (broth micro dilution) method was performed to determine the intended result for fluconazole compared with vitek® 2 ast-ys07 cards.The result for bmd was mic = 2mg/l (susceptible).The customer lot and a random lot of ast-ys07 cards were tested with the vitek® 2 and the result of <=1mg/l (susceptible) was obtained for both lots, duplicating the customer results.With vitek® 2, the mic of 1 mg/l is in essential agreement with the reference mic (2mg/l s, bmd) within 1 doubling dilution, with no category error.The category interpretations based on vitek® 2 breakpoints claimed for fluconazole were: s /=64.The results observed in-house (no presence of macrocolonies no heteroresistance observed), correlate with the external quality control reference results from lab 1 (1,5mg/l ) but not with lab 2 (12mg/l).The alternative method etest® fluconazole (fl) result was mic =1mg/l (susceptible).The investigation concluded that the ast-ys07 cards are performing as expected.No further action is required.

• Brand Name: VITEK® 2 AST-YS07
• Type of Device: VITEK® 2 AST-YS07
• 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5822208
• MDR Text Key: 50437109
• Report Number: 1950204-2016-00078
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 414967
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1