MAUDE Adverse Event Report: BIOMERIEUX, SA TOBRAMYCIN TM 256 US S30

Catalog Number 412478

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Event Description

Intended use: etest® is a quantitative technique for determining the antimicrobial susceptibility of gram-negative and gram-positive aerobic bacteria such as enterobacteriacaea, pseudomonas, staphylococcus and enterococcus species and fastidious bacteria, such as anaerobes, n.Gonorrhoeae, s.Pneumoniae, steptococcus and haemophilus species.The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (mic), in ¿g/ml, of different antimicrobial agents against microorganisms as tested on agar medium using overnight incubation.Description of the issue: a customer in united states notified biomérieux of obtaining out-of-range-low results on quality strain enterococcus faecalis atcc® 29212¿ when using the etest® tobramycin tm 256 us s30 - reference 412478 - lot #1007859110 - expiration date: 30/01/2022.The customer obtained tobramycin mic = 4 ug/ml while the expected range for this qc strain is from 8 ug/ml to 32ug/ml.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Investigation: retained samples for the impacted lot number (ref.412478, 1007859110) were tested in parallel with one internal lot number used as reference (ref.412478, lot 1008624810, expiry date on 2023-03-23).The tests were performed using the following qc strains, using the same qc protocol as that used for the release of each lot number.Three (3) strips of etest® tobramycin were tested per strain for each lot number using mh agar plate from a supplier other than remel.Enterococcus faecalis atcc® 29212¿, escherichia coli atcc® 25922¿, staphylococcus aureus atcc® 29213¿, pseudomonas aeruginosa atcc® 27853¿.For enterococcus faecalis atcc 29212 strain, the investigation reproduced the customer's issue on one (1) of three (3) strips tested (lot 1007859110).The mic value obtained for this strip was 4 ¿g/ml.The two other strips tested from the customer's lot, and all three strips from the reference lot showed results consistent with expectations.The qc results obtained for the three other atcc strains were in accordance with the expected specifications for the investigated etest lot and the reference etest lot.In addition, the retained samples for the customer lot (1007859110) were tested in parallel with a second internal lot number used as reference (ref.412478, lot 1007568010, expiry date on 2021-09-04) using the four qc strains mentioned above.E.Coli atcc 25922, s.Aureus atcc 29213 and p.Aeruginosa atcc 27853 strains were tested with a single type of mh medium.E.Faecalis atcc 29212 strain was tested using three types of mh medium including the mh type used for the three other strains.The results obtained are identical on both lots (lot related to the complaint and reference lot).The reported issue with e.Faecalis atcc 29212 strain (out of range low results) was partially reproduced with one type of mh medium; one strip out of the three tested on the lot 1007859110 and the reference lot showed mic value at 4 ¿g/ml.The issue was not reproduced with the two other types of mh medium.The other three atcc strains tested exhibited results consistent with those expected on the mh media tested.Issue review: on the 06th july 2021, the investigator searched the complaints database for any similar reports on the lot 1007859110.No other complaints were registered for this lot number.Conclusion: the results of quality control obtained during investigation on the impacted etest® tobramycin (tm 256) lot complied with specifications when using two different types of mh medium.The investigator reproduced the customer's issue on e.Faecalis atcc 29212 on the impacted lot and the reference lot when using one type of mh medium.Biomérieux recommended the customer test different mh medium suppliers or different lots of mh medium with the etest qc strains to validate the association between mh medium and etest product.The performance of etest® ® tobramycin (tm 256) (0,016 ¿ 256 g/ml) is within specifications.

• Brand Name: TOBRAMYCIN TM 256 US S30
• Type of Device: TOBRAMYCIN TM 256 US S30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11866572
• MDR Text Key: 281408975
• Report Number: 9615754-2021-00166
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026378875
• UDI-Public: 03573026378875
• Combination Product (y/n): N
• PMA/PMN Number: K102668
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Catalogue Number: 412478
• Device Lot Number: 1007859110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1