MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® VORICONAZOLE

Catalog Number 412490

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

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 s30.The customer reported obtaining an unusual shape result, and the ellipse meets the strip under the lower mic.There are three (3) patients involved in this event with three (3) different sample types; pus, trachea aspiration and catheter.The customer reported the iqc result is not good; the expected range is 0.004 - 0.016 and a mic result obtain was lower than 0.002.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 may be a potential for adverse event if the event were to reoccur while testing a patient isolate; therefore this event is being reported as a malfunction.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: biomérieux performed an investigation on customer strips of lot 1004803990 and the retained samples from lot 1004803990 and lot 1005016560 mentioned by customer in parallel with another batch as a reference.We did not reproduce the issue observed by the customer on atcc strain 90028.The conformity of batches 1004803990 and 1005016560 mentioned by customer was be confirmed with two (2) others qc stains whose candida parapsilosis atcc 22019 and candida krusei atcc 6258.On three (3) clinical strains, we reproduced the customers results with mic very low or ellipse which ends below the strip (less than 0.002) randomly.The strains were susceptible.We confirmed the variability of results obtained by the customer.But the result is considered as acceptable.These results are linked to normal variability intra or inter-batches for antifungals.Indeed, this variability is accepted within two (2) doubling dilutions ((b)(4)) unlike antibiotics.However, these strains have mic very low at the limit of etest® strip mic.These strains are very susceptible.In this case the real mic do not have a clinical interest.It's the same thing with high level of mic.The variability increase at the limit of the strips (close to 0.002 or close to 32mg/l).

• 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; st. louis, MO 63042
• MDR Report Key: 6230904
• MDR Text Key: 64132872
• Report Number: 3002769706-2017-00003
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/10/2017

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: 04/14/2021
• Device Catalogue Number: 412490
• Device Lot Number: 1004803990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1