MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® VORICONAZOLE

Catalog Number 532818

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported a discrepant result (out-of-range-low) for candida albicans, atcc® 90028, associated with etest® voriconazole vo 32 ww f100.The customer had tested two batches of voriconazole in which both gave low results.Customer stated that instead of streaking the plates, they "flow" the plates before they apply the etest®.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the neqas survey sample.Biomérieux investigation will be initiated.

Manufacturer Narrative

A biomérieux investigation was conducted for a discrepant result (out-of-range-low) for candida albicans, atcc® 90028, associated with etest® voriconazole vo 32 ww f100.The investigation involved testing the etest® voriconazole vo 32 (lot 1003390050) customer strips, retained strip samples, and a different lot as reference, with 3 atcc stains (atcc 90028 - atcc 6258 - atcc 22019).The issue observed by the customer with the quality control strains was not reproduced.The customer stated that instead of streaking the plates, they "flow" the plates before they apply the etest®.Inoculation by floating is not the recommended procedure stated in the instructions for use (package insert) and it's necessary for antifungals to swab twice.The investigation concluded the etest® voriconazole vo 32 ww f100 is performing as intended.

• Brand Name: ETEST® VORICONAZOLE
• Type of Device: ETEST® VORICONAZOLE
• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6086590
• MDR Text Key: 59570435
• Report Number: 3002769706-2016-00465
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K082534
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2020
• Device Catalogue Number: 532818
• Device Lot Number: 1004139440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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