MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST AMIKACIN AK 256 US S30; ETEST® AMIKACIN AK 256 US S30

Catalog Number 412218

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of out of range high (ooh) results in association with the etest® amikacin ak 256 us s30 (ref.412218, lot 1007537650) when testing atcc® 27853¿ pseudomonas aeruginosa.The customer tested atcc® 27853¿ pseudomonas aeruginosa multiple times using lot 1007537650 and mueller hinton agar; each test obtained a mic value between 6-12 ¿g/ml.The etest® amikacin ak 256 us s30 instructions for use state the expected result for atcc® 27853¿ pseudomonas aeruginosa is mic between 1-4 ¿g/ml.The customer confirmed the etest® amikacin ak 256 us s30 strips were stored at -20°c and given fifteen (15) minutes to come to room temperature prior to use.Biomérieux customer service advised the customer that the etest® amikacin ak 256 us s30 strips instructions for use (ifu) handling section states to allow thirty (30) minutes for strips held at -20°c to come to room temperature prior to testing.The customer performed qc testing following the advice of biomérieux customer service; repeat testing also obtained out of range high results.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states regarding out of range high (ooh) results in association with the etest® amikacin ak 256 us s30 (ref.412218, lot 1007537650) when testing atcc® 27853¿ pseudomonas aeruginosa.The customer tested atcc® 27853¿ pseudomonas aeruginosa multiple times using lot 1007537650 and mueller hinton agar; each test obtained a mic value between 6-12 ¿g/ml.A biomérieux internal investigation has been completed with the following results: the retained samples for the impacted lot number 1007537650 reported was tested in parallel with one internal lot number used as a reference (lot 1007537660).The tests were performed using the quality control (qc) strains pseudomonas aeruginosa atcc® 27853¿, staphylococcus aureus atcc® 29213¿, enterococcus faecalis atcc® 29212¿ and escherichia coli atcc® 25922¿ according to the qc protocol used for the release of each lot number.Concerning the impacted lot 1007537650 and the reference lot 1007537660, the results were within specifications for the four strains tested.Notably for the strain pseudomonas aeruginosa atcc 27853, for which the obtained minimum inhibitory concentrations (mic) values were at 4 ¿g/ml (mic expected qc range for atcc 27853 : 1 - 4 ¿g/ml).Additional testing was performed on lot number 1007537650 to evaluate its performance.To complete this testing, 49 pseudomonas aeruginosa clinical strains and the qc strain pseudomonas aeruginosa atcc 27853 were tested with the impacted lot 1007537650 and another lot used as a reference lot (lot 1006836020).The results obtained with the 49 pseudomonas aeruginosa strains and etest ak 256 strips tests were compared to the results obtained with the reference methods agar dilution (ad) and broth micro dilution (bmd).The qc strain pseudomonas aeruginosa atcc 27853 showed results within specifications for the impacted lot 1007537650, and the reference lot.Specifically, the mic values obtained were 3 ¿g/ml for lot 1007537650 and the reference lot.Regarding the 49 pseudomonas aeruginosa strains, the results obtained with the etest ak 256 lots are in agreement with the results obtained with the reference methods ad and bmd.In conclusion, a performance issue was not observed for the impacted etest ak 256 lot number 1007537650.

• Brand Name: ETEST AMIKACIN AK 256 US S30
• Type of Device: ETEST® AMIKACIN AK 256 US S30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10345325
• MDR Text Key: 203854605
• Report Number: 9615754-2020-00125
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026376567
• UDI-Public: 03573026376567
• Combination Product (y/n): N
• PMA/PMN Number: K970210
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Catalogue Number: 412218
• Device Lot Number: 1007537650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1