MAUDE Adverse Event Report: BIOMERIEUX SA CEFOTAXIME CTL 32 US S30

Catalog Number 412280

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer called with out of range results for qc testing using etest cefotaxime ctl 32 us s30, (b)(4), lot 1004047910.Quality control testing for pseudomonas aeruginosa 27853 were out of range (high) and e.Coli 25922 was acceptable.Additional set-up and testing performed with the same results.Product from a different lot are being sent to the customer for use.An internal investigation has been launched.There was no reported death or serious injury associated with the referenced event.

Manufacturer Narrative

This report was initially submitted following notification that a customer in the united states reported pseudomonas aeruginosa atcc® 27853 tm out-of-range-high (mic >=32) in association with etest® cefotaxime ctl 32.Internal investigation was conducted.Etest® cefotaxime ctl 32 is only recommended for streptococcus and fastidious strains.Etest® cefotaxime ctl 32 is not adapted for pseudomonas aeruginosa.This is why pseudomonas aeruginosa atcc® 27853 tm is not recommended for quality control testing against this product.Instructions for use supplementary insert us 15221 states to "please consult the footnotes in the latest clsi tables for further comments and clarification.Interpretive criteria may be different." in clsi, there are no break points for pseudomonas aeruginosa.The etest® cefotaxime ctl 32 product is performing in accordance to performance claims.

• Brand Name: CEFOTAXIME CTL 32 US S30
• Type of Device: CEFOTAXIME CTL 32 US S30
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5083567
• MDR Text Key: 26309538
• Report Number: 3002769706-2015-00087
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Report Date: 07/21/2015

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: 06/01/2017
• Device Catalogue Number: 412280
• Device Lot Number: 1004047910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1