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

Catalog Number	414967
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported the occurrence of a false susceptible fluconazole result for candida albicans in association with the vitek® 2 ast-ys07 test kit.Etest fluconazole provided a resistant result.Repeat testing obtained the same respective results.The customer reports a delay in reporting due to the additional testing performed.The patient was treated with a different antimycoticum.The customer sent the patient strain to a reference laboratory.The reference laboratory obtained results of resistant to fluconazole (test method unknown), confirming the vitek® 2 ast-ys07 result to be discrepant.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.Internal biomérieux investigation will be conducted.
Additional Manufacturer Narrative
A biomerieux investigation was initiated due to a false susceptible fluconazole result on the ast-ys07 card for a candida albicans isolate, compared to etest® and reference lab results (resistant).The customer also observed the same issue on voriconazole.The reference method was performed to determine the intended results for fluconazole and voriconazole bmd (broth microdilution), compared with vitek® 2 (v6.01) and ast-ys07 cards.Category interpretations based on vitek® 2 breakpoints were: fluconazole: s/=64.Voriconazole: s/=4.Two different lots of ast- ys07 cards were tested: the customer lot 287394320 and a random lot 287389420.Test results obtained with bmd: - fluconazole reference mic >64mg/l resistant.-voriconazole reference mic>16 mg/l resistant.Results confirmed those obtained by the reference institute.On vitek® 2, the results obtained on both lots tested were flu mic <= 1mg/l s and vrc mic <=0.125mg/l s.The investigation duplicated the customer results.The investigation concluded the submitted isolate has an atypical biochemical profile.

• Brand Name: VITEK® 2 AST-YS07 TEST KIT
• Common Device Name: VITEK® 2 AST-YS07 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 5949551
• Report Number: 1950204-2016-00122
• Device Sequence Number: 158720
• Product Code: NGZ
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 414967
• Device Lot Number: 287394320
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1