MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST IMIPENEM RELEBACTAM IPR US S30; ETEST® IMIPENEM RELEBACTAM IPR US S30

Catalog Number 420927

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 the united stated notified biomerieux of obtaining overestimated mic results in association with etest® imipenem relebactam ipr us s30 (ref.420927, lot 1008390030) while performing validation testing with seven (7) strains of pseudomonas aeruginosa including pseudomonas aeruginosa atcc® 27853¿.The customer tested the pseudomonas aeruginosa strains twice using 150mm remel plain mueller hinton agar plates and 0.45% saline solution with a mcfarland density of between 0.5 and 0.53.Overestimated imipenem relebactam mic results were obtained for each isolate for both initial and repeat testing.Biomerieux customer service advised the customer to use a 0.85% saline solution as instructed in the etest® imipenem relebactam ipr us s30 instructions for use (ifu).The customer repeated testing using a 0.85% saline solution following the instructions for use.All seven (7) isolates obtained overestimated mic results with four (4) false resistant results interpreted using the clsi 2021 breakpoints with a susceptible mic result =2 and resisisant result >8.The results of the false resistant results are listed below.Pseudomonas aeruginosa strain 512 expected result2 ug/ml - susceptible retest result: 12 ug/ml ¿ false resistant result pseudomonas aeruginosa strain 514 expected 2 ug/ml - susceptible retest result: 6 ug/ml ¿ false resistant result pseudomonas aeruginosa strain 526 expected 2 ug/ml - susceptible repeat result: 32 ug/ml false resistant result pseudomonas aeruginosa strain 528 expected 2 ug/ml - susceptible repeat result: 12 ug/ml false resistant result as there are no patients associated with these quality control strains, there is no adverse event related to any patient's state of health.Biomerieux has initiated an internal investigation.

Manufacturer Narrative

The results reported led to category error (resistant results instead of susceptible) compared to the expected results mentioned in the cdc panel.These issues were observed by the customer on the etest® imipenem / relebactam (ipr) s30, reference 420927, lot numbers 1007607290 (expiry date on 24 jun 2021), 1007888870 (expiry date on 09 nov 2021), 1008390030 (expiry date on 06 aug 2022) and 1008598350 (expiry date on 04 dec 2022).Investigation.Retained samples for the three (3) different lots of etest® ipr were tested during the investigation.Tests were performed using the quality control (qc) strains; pseudomonas aeruginosa atcc® 27853¿, escherichia coli atcc® 25922¿, escherichia coli atcc® 35218¿, klebsiella pneumoniae atcc® baa 1705¿ and klebsiella pneumoniae atcc® 700603¿ according to the qc protocol used for the release of each lot.The results obtained complied with specifications for the five (5) strains and the three (3) etest® ipr lots tested.The fourteen (14) pseudomonas aeruginosa strains from the cdc panel were tested on the three (3) lots mentioned above, compared to bmd method.The mic overestimations were confirmed.Additional tests were performed using 45 enterobacteriaceae strains and 30 pseudomonas aeruginosa strains.This study showed no performance issue with enterobacteriaceae strains but confirmed mic overestimations for pseudomonas aeruginosa strains.Complaint review.The investigator reviewed the historical complaints database to find any similar complaints which were previously reported against etest® ipr including references 420927 (s30 us) and 420925 (s30 ww).Apart from the records related to this issue, no other complaints were registered for product reference 420927, nor were any registered for the product reference 420925.Conclusion.The investigator confirmed a performance degradation of the product etest® ipr leading to an increase major error rate for pseudomonas aeruginosa strains.Both references of etest® ipr, 420925 and 420927, are impacted by this performance issue.Corrective and preventive action.A field safety corrective action (fsca-5230) has been issued 24-jun-2021, with a customer letter.This customer letter will inform the users that a confirmation is needed (using an alternative method) on pseudomonas aeruginosa strains for which a resistant or intermediate result has been obtained with etest® imipenem relebactam ¿ ref.420925 and 420927.Furthermore, a corrective action and preventive action plan (capa) is in progress at manufacturing site level to identify the root cause related to this issue and determine the necessary actions.

• Brand Name: ETEST IMIPENEM RELEBACTAM IPR US S30
• Type of Device: ETEST® IMIPENEM RELEBACTAM IPR US S30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11778360
• MDR Text Key: 281015562
• Report Number: 9615754-2021-00139
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026551544
• UDI-Public: 03573026551544
• Combination Product (y/n): N
• PMA/PMN Number: K191953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Catalogue Number: 420927
• Device Lot Number: 1008390030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1