MAUDE Adverse Event Report: BIOMERIEUX, SA DAPTOMYCIN DPC 256 US S30®

Catalog Number 412323

Device Problem High Test Results (2457)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

Intended use.Etest® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious gram-negative and gram-positive aerobic bacteria and fastidious bacteria.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 tested on agar media after overnight incubation.Description of the issue.A customer in the united states notified biomérieux of obtaining false resistant daptomycin with vancomycin-resistant enterococci (vre) isolates when testing three patient isolates with the etest daptomycin dpc 256 us s30 - reference (b)(4).(lot#1009977190 - expiration date : 12/04/2025) in association with mueller hinton plates.Indeed, the customer indicates having obtained three vre isolates tested as daptomycin resistant.They also noticed inconsistent results with daptomycin etest when using small vs large mueller hinton plates.Considering that resistant daptomycin is a rare occurrence, the strains were sent to an external laboratory (arup) for testing.The broth microdilution results from arup were susceptible.The customer indicated that only the arup results were reported to the patient charts.Customer confirmed that no discrepant patient results were reported out.At the time of the assessment, there is no indication or report from the customer that this event led to death, serious injury, or serious deterioration in the state of health for any patient.This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting.Per biomérieux internal standard operating procedures, false resistant result in association with etest is considered to be a potentially reportable event (pre).A false resistant result could have a negative influence on the medical diagnosis and treatment requiring professional medical intervention.A resistant result eliminates the drug as a choice for treatment.A false resistant result could have a negative influence on the treatment decision, as resistant results limit the treatment options available to the clinician.The patient may not receive the most effective antimicrobial.The patient could receive an alternative antibiotic and experience more side effects.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.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context ******************** a customer in the united states notified biomérieux of obtaining false resistant daptomycin with vancomycin-resistant enterococci (vre) isolates with the etest daptomycin dpc 256 us s30 - reference (b)(4) (lot#1009977190 - expiration date : 12/04/2025) in association with mueller hinton plates.The customer indicated having the same issue when using the etest lot#1010146860.It has been documented in the complaint (b)(4).Therefore, the issue was observed on the etest® daptomycin (dpc 256), product reference (b)(4), lot numbers 1009977190 (expiry date 12 apr 2025) and 1010146860 (expiry date 19 jul 2025).Investigation results *********************** **retained samples analysis** biomérieux retains samples of every lot number released to the market.The retained samples from the impacted lot numbers 1009977190 were tested in parallel with an internal lot number used as a reference lot (reference (b)(4), lot 1009548780, expiry date 22 aug 2024).The tests were performed by using the quality control (qc) strains staphylococcus aureus (b)(6), enterococcus faecalis (b)(6) and streptococcus pneumoniae(b)(6)according to the quality control protocol used for the release of each lot number.Compliant results were obtained for the three strains tested on all etest lot numbers.**strains return analysis** four enterococcus faecium strains have been received from the customer for analysis.1) testing of patient sample using reference method the reference method broth micro dilution (bmd) was performed and the minimum inhibitory concentration (mic) values obtained were 4 g/ml for the four strains tested.Following the clsi breakpoints 2024 for enterococcus faecium / daptomycin [s = 4 ¿ r = 8], the strains are on the breakpoints so, within one doubling dilution, the category can be susceptible (s) or resistant (r).The four strains can be considered as borderline strains for daptomycin.2) testing of patient sample or reference material using manufacturer's device the four strains were tested in parallel on etest daptomycin (dpc 256) lot numbers 1009977190 ( customer lot) ; 1010146860 (customer lot ) and on the lot number 1009548780 used as reference lot.Among the four strains tested, two strains showed resistant results on the three etest lots tested with mic values at 8 g/ml.These two strains are within essential agreement compared to the bmd method.The third strain showed resistant results (mic equal to 8 g/ml) for etest lot numbers 1009977190 (related to the complaint) and 1009548780 (reference lot) and showed susceptible results (mic equal to 4 g/ml) for the etest lot number 1010146860.This strain is also within essential agreement compared to the bmd method.Concerning the fourth strain, resistant results were obtained for the three etest lot numbers tested with mic values equal to 8 g/ml for the etest reference lot and equal to 16 g/ml for the two etest lot 1009977190 and lot 1010146860 for this strain, essential agreement error is observed for the two lot numbers related to the complaints while the etest reference lot is within essential agreement compared to the bmd method.Considering the global results obtained during the investigation, the etest daptomycin (dpc 256) performances are not questioned as the etest lots tested are within essential agreement compared to the bmd method for three strains tested.**complaint analysis** the complaint analysis did not indicate any systematic quality issue for the product etest® daptomycin (dpc 256), reference (b)(4).Conclusion *********************** no product issue was observed on the lot numbers 1009977190 and 1010146860 during the tests performed on the retained samples with quality control strains.The etest lots tested are within essential agreement compared to the bmd method for three strains out of four.Following the clsi breakpoints 2024 for enterococcus faecium / daptomycin [s = 4 ¿ r = 8] and the results obtained with bmd, the four returned strains are on the breakpoints and can be considered as borderline strains.This explained the difference of category we can observed between bmd (s results) and etest dpc (r results) as, within one doubling dilution, the category can be susceptible (s) or resistant (r).The complaint trend analysis does not show any negative trend for the product etest® daptomycin (dpc 256), reference (b)(4).Based on these elements, the performance of the two complained etest lot numbers are not questioned.

• Brand Name: DAPTOMYCIN DPC 256 US S30®
• Type of Device: DAPTOMYCIN DPC 256 US S30®
• Manufacturer (Section D): 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: 18002493
• MDR Text Key: 326467718
• Report Number: 9615754-2023-00044
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026376550
• UDI-Public: 03573026376550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412323
• Device Lot Number: 1009977190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Date Device Manufactured: 04/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1