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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-YS08 TEST KIT

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BIOMERIEUX, INC. VITEK® 2 AST-YS08 TEST KIT Back to Search Results
Catalog Number 420739
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in (b)(6) reported the occurrence of false susceptible fluconazole and false susceptible flucytosine results for a candida norvegensis eeq strain in association with the vitek® 2 ast-ys08 test kit (ref 420739).Vitek® 2 provided the following results: fluconazole mic = 8 (susceptible), expected result is resistant.Flucytosine mic = 4 (susceptible), expected result is resistant.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient associated with this survey isolate.A biomérieux internal investigation will be initiated.
 
Manufacturer Narrative
This report was initially submitted in response to a customer in (b)(6) reporting the occurrence of false susceptible flucytosine results for a candida norvegensis eeq strain in association with the vitek® 2 ast-ys08 test kit (ref 420739).Vitek® 2 obtained flucytosine mic = 4 (susceptible).An internal biomérieux investigation was performed that included testing for both fluconazole (flu) and flucytosine (fct) results with a strain of candida norvegensis on vitek® 2 ast-ys08 cards.This strain is from a biologie prospective survey (mycology 2017- sample 3a).Id testing : identification was confirmed to candida norvegensis on vitek 2 yst id card (lot 2430356103).Ast testing: · reference method to determine the intended result for fluconazole and flucytosine: broth microdilution, method used to develop the formularies "flu02n" / "fct02n" (in ast-ys08 card).· flu mic = 16 mg/l intermediate · fct mic = 8 mg/l intermediate interpretation according to vitek 2 breakpoints in v7.01 : fda 2009 breakpoints for candida / fluconazole s /=64.Fda 2012 breakpoints for candida / flucytosine : s /=32.Note: for antifungals, essential agreement between vitek® 2 card and reference method mics is +/- 2 doubling dilutions.· products & system incriminated: -ast -ys08 on vitek 2 v7.01 three (3) vitek 2 ast-ys08 lots were tested from sabouraud dextrose agar (sda).Vitek 2 gave the following results on the three (3) lots tested: **flu mic = 8 mg/l susceptible **fct mic = 4 mg/l susceptible the vitek 2 results are within essential agreement with the reference mic within +/- 1 doubling dilution.Conclusion: -the customer results were duplicated on the ast-ys08 cards (mic flu= 8 mg/l s and fct mic=4 mg/l s).-the vitek 2 ast-ys08 cards perform as intended.The vitek 2 values are within essential agreement with the reference results obtained in bmd.-the reference mic for both fluconazole and flucytosine are in the middle of the breakpoints, so the strain can be susceptible or resistant within +/- 2 doubling dilutions.-->borderline strain.
 
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Brand Name
VITEK® 2 AST-YS08 TEST KIT
Type of Device
VITEK® 2 AST-YS08 TEST KIT
Manufacturer (Section D)
BIOMERIEUX, INC.
595 anglum road
hazelwood MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC.
595 anglum road
hazelwood MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key7128846
MDR Text Key95871499
Report Number1950204-2017-00456
Device Sequence Number1
Product Code NGZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K133952
Number of Events Reported1
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 05/11/2018
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
Device Operator Health Professional
Device Expiration Date09/19/2018
Device Catalogue Number420739
Device Lot Number2880297203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2017
Initial Date FDA Received12/19/2017
Supplement Dates Manufacturer Received04/17/2018
Supplement Dates FDA Received05/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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