MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® CIPROFLOXACIN CI 32 WW S30

Catalog Number 412311

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) notified biomerieux of discrepant results using etest ciprofloxacin ci 32 for a pseudomonas aeruginosa qc sample (b)(4).The expected result is 0,25 - 1<(>,<).The customer reported a result of 0,125.The customer reported repeating the test more times with the same result, 0,125.The strain was used for other qcs with no reported issue.An internal biomerieux investigation will be conducted.

• Brand Name: ETEST® CIPROFLOXACIN CI 32 WW S30
• Type of Device: ETEST® CIPROFLOXACIN
• 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: 5610943
• MDR Text Key: 43785378
• Report Number: 3002769706-2016-00074
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K981138
• 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: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2020
• Device Catalogue Number: 412311
• Device Lot Number: 1003894050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2015
• 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