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

Catalog Number 414967

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the (b)(6) reported the occurrence of discrepant ast results (intermediate and/or susceptible) for a (b)(6) survey sample (b)(6) (candida albicans) in association with the vitek 2 ast-ys07 test kit.Fluconazole i/s (mic = 4mg/l).Voriconazole s (mic <= 0.12mg/l).The expected results were resistant.Fluconazole i/s (mic > 64mg/l).Voriconazole s (mic > 8mg/l).Note: in the final report from (b)(6), fluconazole and voriconazole were not graded since the "levels of concordance with fluconazole (63%) and voriconazole (59%) did not reach the requisite 80% of participants." the customer repeated testing using the vitek 2 ast-ys07 test kit and obtained susceptible results of <=1mg/l for fluconazole and <=0.12mg/l for voriconazole.It is unknown if any alternate method was employed to confirm the expected result.There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to any patient's state of health.There is no patient directly associated with the survey sample.Internal biomerieux investigation was conducted.Investigational testing included the following.Vitek 2 yst id test kit confirmed the organism identification to candida albicans.Broth microdilution (bmd): fluconazole mic >64mg/l (r) and voriconazole mic>16mg/l (r).Vitek 2 ast-ys07 test kit (from sda media, customer lot and random lot): customer lot: fluconazole mic =16 mg/l (i) and voriconazole mic = 1 mg/l (s).Random lot: fluconazole mic =16 mg/l (i) and voriconazole mic = 1 mg/l (s).Vitek 2 ast-ys07 test kit (from cos media, customer lot): customer lot: fluconazole mic =<=1 mg/l (s) and voriconazole mic <= 0.125 mg/l (s).Etest: fluconazole mic >= 256mg/l (r) and voriconazole mic >= 32 mg/l (r).It's possible that the environment of the vitek 2 card and shorter vitek 2 incubation time, compared to other methods (e.G.Bmd, etest), does not provide the optimal environment for this strain.The investigation concluded the (b)(6) survey organism is an atypical strain for vitek 2 testing and that the vitek 2 yeast (yst) identification (id) test kit is performing as intended.

• 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5921065
• MDR Text Key: 53729759
• Report Number: 1950204-2016-00115
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2017
• Device Catalogue Number: 414967
• Device Lot Number: 287375612
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2015
• 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