MAUDE Adverse Event Report: BIOMÉRIEUX, SA ETEST ESBL CT/CTL 16/1 WW B30; ETEST® ESBL CT/CTL 16/1 WW B30

Catalog Number 532200

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

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biom¿rieux of obtaining an out of range low result while testing an klebsiella pneumonia atcc¿ 700603" strain using the etest¿ esbl ct/ctl 16/1 ww b30 (reference # 532200, lot # 1007956350, expiry: 18feb2021).The results reported by the customer are : ct = 0.38 ; expected cqi ct 1 - 4 / non-compliant.Ctl = 0.19 ; expected cqi ctl -> 0.125 - 1 / compliant a slight ellipse deformation was present on the ct ellipses but not very visible and difficult to interpret.The customer placed two strips on the plates which made it harder to see the ellipse.The customer also performed a test on klebsiella pneumonia atcc¿ 700603" using vitek 2 ast-n233 test kit with positive esbl results.Per the supplemental package etest esbl product insert 16245 a, footnote 3 of table 2.Quality control specifications for etest esbl ct/ctl, tz/tzl and pm/pml strips, "mic ratio may be = 8 but deformation of the ct or pm ellipse is indicative of esbl." this note is also in the original etest package insert (15210 c), "mic ratio of = 8 for the two reagent sides or a phantom zone or deformation of either ellipse is indicative of esbl or mbl." the customer performed a retest using a single strip on the plates.The retest was performed using the initial lot and a different lot.The qc passed on the retest.The customer obtained a deformed ellipse in pm and ct side.A deformed ellipse is a result considered as positive for esbl phenotype.There is no patient associated with this qc strain; therefore, there is no adverse event related to any patient's state of health.A biom¿rieux internal investigation has been initiated.Note: reference (b)(4) is not registered in the united states.The u.S similar device is product reference 532200.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding an out of range low result while testing an klebsiella pneumonia atcc® 700603¿ strain using the etest® esbl ct/ctl 16/1 ww b30 (reference # 532200, lot # 1007956350, expiry: 18feb2021).No observations or nonconformities were observed during the manufacturing process and quality control for this lot.The four (4) strains tested during quality control for batch release, which included klebsiella pneumonia atcc® 700603¿ strain, all complied with specifications.The customer performed a new qc test with the strain klebsiella pneumoniae atcc 700603 and the etest® esbl ct/ctl 16/1 ww b30 lot number 1007956350 (reference (b)(4).The test was carried out strictly in accordance with the biomérieux technical recommendations, and the customer obtained compliant results compared to the specifications.The out of range low result was not reproduced.According to the investigation, there is no reconsideration of etest® esbl ct/ctl 16/1 ww b30 lot 1007956350 (reference (b)(4) performance.See section h10.

• Brand Name: ETEST ESBL CT/CTL 16/1 WW B30
• Type of Device: ETEST® ESBL CT/CTL 16/1 WW B30
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 39390 ; FR 39390
• MDR Report Key: 11467128
• MDR Text Key: 271682034
• Report Number: 9615754-2021-00028
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K001547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Catalogue Number: 532200
• Device Lot Number: 1007956350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1