MAUDE Adverse Event Report: BIOMERIEUX, SA VORICONAZOLE VO 32 WW S30 - 412490

Catalog Number 412490

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

Intended use: etest is an agar-based gradient technique for quantitative antifungal susceptibility testing (afst).The system comprises a predefined concentration gradient of a specific antifungal agent which is used to determine the minimum inhibitory concentration (mic), in ¿g/ml, that inhibits the growth of the test organism under defined testing conditions.Description of the issue: this complaint has been created internally following the review of a scientific publication "evaluation of the sensititre yeastone and etest in comparison with clsi m38-a2 for antifungal susceptibility testing of three azoles, amphotericin b, caspofungin, and anidulafungin, against aspergillus fumigatus and other species, using new clinical breakpoints and epidemiological cutoff values" written in brazil by.Melhem et al.Which documents performance issues of several etest reference including etest voriconazole vo 32 ww s30 - reference 412490 ( lot not specified) when testing aspergillus sp.The publication reported thirty-three (33) major errors (me) and two (2) minor errors (mie).Moreover, a gap between the performances claimed and those highlighted in the article is observed : voriconazole (vcz) ea = 87,3% (48/55) ca = 36,4% (20/55) me n=33 mie n=2 (documented in this complaint) performance claimed : ea = 99 %.Anidulafungin (and): ea = 66,7% (14/21) ca = not applied ( documented in (b)(4)) performance claimed : ea = 96 %.Itraconazole (itc): ea = 82,8% (53/64) ca = 90,6% (58/64) vme n=5 me n=1 (documented in (b)(4)) performance claimed : ea = 94 %.Amphotericin b (amb): ea = 82,1% (69/84) ca = 95,2% (80/84) me n=4 (documented in (b)(4)) performance claimed : ea = 90 % the publication indicates that the isolates were originally recovered from 106 patients of hc-fmusp, brazil.There is no indication that the results have been used for medical decision.This discrepancy was reviewed for vigilance reporting according to 21 cfr 803 concerning medical device reporting.Biomérieux internal standard operational procedures states that a false resistant result could have a negative influence on the treatment decision.This limits the treatment options available to the clinician, leading to possible less effective or not appropriate drug.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.Moreover, the reference 412489 which is equivalent of the etest voriconazole vo 32 ww s30 - reference 412490 - is sold in the united states market.A biomérieux internal investigation will be initiated.

• Brand Name: VORICONAZOLE VO 32 WW S30 - 412490
• Type of Device: VORICONAZOLE VO 32 WW S30 - 412490
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: pauline prévitali ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15843773
• MDR Text Key: 307995411
• Report Number: 9615754-2022-00131
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• 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