MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK®2 AST-N350 TEST KIT

Catalog Number 421037

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the (b)(6) notified biomérieux of incorrect results associated with vitek®2 ast-n350 test kit (reference 421037).The customer reported obtaining incorrect results for a (b)(4) sample (distribution 4214 specimen 4179).The isolate was reconstituted per (b)(4) recommendations and placed on a blood agar plate.After overnight incubation, a subculture was performed on a blood agar, the results were as follows: piperacillin-tazobactam mic value = 16mg/l, intermediate; ertapenem mic value= 0.25 mg/l, susceptible; and the organism was identified as an esbl and ampc producer, no additional.Tests were performed to confirm the esbl positive.Expected results for this (b)(4) sample were the following: piperacillin-tazobactam mic value >= 128mg/l, resistant, ertapenem mic value= 4mg/l, resistant, esbl status negative.Retesting was performed using biomérieux sheep blood agar and the customer obtained the same results.This event occurred during an external quality control test; therefore no patient results were impacted.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed due to discrepant results on piperacillin/ tazobactam (tzp) and ertapenem (etp) with e.Coli neqas distribution 4214 sample # 4179 on vitek® 2 v7.01 ast-n350 card.Identification of the neqas strain was confirmed and testing included one (1) card of each customer lot 7900559403 called cl1, 7900390103 called cl2, and one (1) card of a random lot 7900428203 called rl.The broth microdilution for tzp and for etp was also performed.The reference methods (broth microdilution, bmd), which were the method used for piperacillin/ tazobactam development (formulation tzp03n) and for etp development (etp02n formulation) on ast-n350 card gave: tzp mic = 128 mg/l (r) and etp mic = 2 mg/l (r) on vitek 2 v7.01 (aes parameters: global european based + phenotypic): ast-n350 cards were tested from cba (cos bmx) subculture.One (1) card of two customer lots (7900559403 called cl1, and 7900390103 called cl2) , and one (1) card of a random lot (7900428203 called rl) were tested from cba (cos bmx) subculture.The results were the same fro all three (3) lots: tzp mic = 16 mg/l intermediate.Etp mic = 0.25 mg/l susceptible.Conclusion: the false tzp intermediate customer result was reproduced in-house.The false etp susceptible result was reproduced in-house.The biomérieux study confirms an underestimation of ertapenem.Note: the vitek 2 proposed an ampc or esbl phenotype, and the intended result by neqas was ampc , so vitek 2 proposed the correct phenotype.Quality system review of the most recent quarterly trend report, q1 2018, did not identify these complaints as systemic quality issues.

• Brand Name: VITEK®2 AST-N350 TEST KIT
• Type of Device: VITEK®2 AST-N350 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: tiffany hall ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 7553525
• MDR Text Key: 110051722
• Report Number: 1950204-2018-00202
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152075
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2018
• Device Catalogue Number: 421037
• Device Lot Number: 7900390103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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