MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-P633 TEST KIT

Catalog Number 414994

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the netherlands reported to biomérieux a false susceptible linezolid result for a (b)(6) staphylococcus aureus strain ((b)(6) 4231 ears-net, strain 4318) in association with the vitek® 2 ast-p633 test kit.The mic value for linezolid was 2 (susceptible).The expected result for this (b)(6) strain is mic 16 (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 directly associated with the (b)(6) strain.It is important to note that the ast-p633 instructions for use contain a limitation regarding the corresponding linezolid formulation that states: "the ability of the ast card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing" and includes staphylococcus species.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer from the (b)(6) had reported to biomérieux a false susceptible linezolid (lnz) result for a neqas staphylococcus aureus strain (neqas 4231 ears-net, strain 4318) in association with the vitek® 2 ast-p633 test kit.An internal biomérieux investigation was performed, including evaluation of the isolate submitted by the customer.Identification of the submitted organism was confirmed, and testing included one (1) card from the customer lot (7330319203 called cl) of vitek 2 ast-p633 cards, as well as one (1) card from a random lot (7330444103 called rl).The reference method used for the development of the incriminated drug was performed in parallel of vitek 2 testing : agar dilution (ad), method used for linezolid development (lzo2n formulary) in ast-p633 card, gave lnz mic = 2 mg/l susceptible.On vitek 2 v7.01 ast-p633 card (aes parameters : eucast + phenotypic) vitek 2 gave : lnz mic = 2 mg/l susceptible for both lots used.The lnz value is within essential agreement with the reference mic (ad = 2 mg/l susceptible), with no category error.Customer result is reproduced in-house (mic lnz = 2 mg/l susceptible).Conclusion: the lnz customer result is reproduced in-house whatever the lots used : mic lnz = 2 mg/l (s).The vitek 2 ast-p633 cards performed as intended and no further action is required.Notes : - the investigation results are correlated with most of the eeq participants reported results (87.6 % of susceptible results).- ast-p633 card has a limitation for staph species and linezolid that states : "the ability of the ast card to detect resistance with the following combination (s) is unknown because resistant strains were not available at the time of comparative testing : linezolid : enterococcus spp, staphylococcus spp, streptococcus agalactiae.".

• Brand Name: VITEK® 2 AST-P633 TEST KIT
• Type of Device: VITEK® 2 AST-P633 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: candace martin ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 7648612
• MDR Text Key: 113039556
• Report Number: 1950204-2018-00239
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K032766
• 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: 10/09/2018

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 Date: 10/11/2018
• Device Catalogue Number: 414994
• Device Lot Number: 7330319203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1