MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 AST-P586 TEST KIT

Catalog Number 22276

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a false susceptible vancomycin result for an enterococcus strain from a patient's urine sample, in association with the vitek® 2 ast-p586 test kit (lot 3660564203).The patient was not on antibiotic therapy.The vre (vancomycin resistant enterococcus) phenotype was confirmed by pcr.The sample was also positive on chromid® vre agar.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.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated due to a false susceptible vancomycin (va) result associated with the vitek® 2 (v7.01) ast-p586 cards invovling an enterococcus faecium.The reference method (broth microdilution, bmd), which was the method used for vancomycin development (formulation va04n) on vitek 2 ast-p586, gave: bmd va mic > 64 mg/l r.On vitek 2 v7.01 (aes parameters : eucast + phenotypic), four (4) ast-p586 cards (one from the customer lot n°1, cl1 3660564203, one from the customer lot n°2, cl2 3660477403, one from the customer lot n°3, cl3 3660600403, and one from a random lot rl 3660410203) were tested.Cl1/cl2/cl3: va mic = 8 mg/l r with "van b like" phenotype.Rl: va mic <= 0.5 mg/l s with "wild" phenotype.The mic values on cl1, 2 and 3 were an essential agreement error compared to the reference result without category error.The false susceptible vancomycin on vitek 2 was reproduced on the rl (<=0.5 mg/l).This result is an essential agreement error comparing to the reference result leading to a very major category error.The underestimation of vancomycin on the vitek 2 ast-p586 card was confirmed in-house.This underestimation can lead to a non-detection of the van b like phenotype on rl only.A complaint and trend review were performed.No action was determined to be necessary at this time.

• Brand Name: VITEK® 2 AST-P586 TEST KIT
• Type of Device: VITEK® 2 AST-P586 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: debra broyles ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7566597
• MDR Text Key: 110598590
• Report Number: 1950204-2018-00209
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072668
• 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,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2019
• Device Catalogue Number: 22276
• Device Lot Number: 3660564203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1