MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® ITRACONAZOLE

Catalog Number 525818

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 having issues with the mic on qc while using; etest itraconazole it 32 ww f100.The results are as follows; both c.Albicans (atcc 90028) and c.Parapsilosis get an mic of 0.032.There is no evidence/indication of the following: injury or death to a patient, evidence that a patient underwent any unnecessary medical procedure due to the reported event, physician alleging the reported event caused him/her to provide incorrect treatment.

Manufacturer Narrative

An internal investigation was initiated due to the report of low mic results with etest itraconazole and two (2) atcc strains: candida parapsilosis atcc 22019 and candida albicans atcc 90028.Results of the internal investigation are as follows: since 2010, there has been only one (1) complaint about this molecule.Inoculation by floating is not within the recommendations of intended use and it is also necessary for antifungals to swabbed twice.Recommendation of package insert: soak a sterile, non-toxic and not too tightly spun swab in the inoculum suspension and remove excess fluid by pressing it against the inside wall of the test tube.Carefully streak the entire agar surface three times, rotating the plate 60 degrees each time to evenly distribute the inoculum.Soak the swab again and repeat the streaking procedure a second time.Alternatively, use retro c80 (rota-plater, biomérieux) to efficiently streak the inoculum over the agar surface and then soak the swab again before streaking a second time.Allow excess moisture to be absorbed for approximately 15 to 20 minutes so that the surface is completely dry before applying the etest gradient strips.The conformity of this batch was confirmed with three (3) atcc stains (atcc 90028 - atcc 6258 - atcc 22019).Testing was performed on the customer's strips and the retained samples corresponding to the batch 1003467650 in parallel with another batch as reference.Result- unable to reproduce the customer's observation with the quality control strains.

• Brand Name: ETEST® ITRACONAZOLE
• Type of Device: ETEST® ITRACONAZOLE
• 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: 5498174
• MDR Text Key: 40275478
• Report Number: 3002769706-2016-00053
• Device Sequence Number: 1
• Product Code: NGZ
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2017
• Device Catalogue Number: 525818
• Device Lot Number: 1003467650
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2014
• 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