MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® CEFTAZIDIME TZ

Catalog Number 412293

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported issues while qc testing using etest ceftazidime tz 256 ww s30.Quality control testing was repeated three times for p.Aeruginosa atcc 27853 - clsi = 1-4 result = 0.5.

• Brand Name: ETEST® CEFTAZIDIME TZ
• Type of Device: ETEST® CEFTAZIDIME TZ
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5488559
• MDR Text Key: 39940983
• Report Number: 3002769706-2016-00045
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971694
• 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
• Report Date: 02/25/2016

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: 09/07/2017
• Device Catalogue Number: 412293
• Device Lot Number: 1004280350
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2015
• 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