MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST PIPERACILLIN/TAZOBACTAM (P/T) WW S30; ETEST® PIPERACILLIN/TAZOBACTAM (P/T) WW S30

Catalog Number 421166

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 biomérieux of obtaining false susceptible piperacillin/tazobactam (tzp) results for a klebsiella pneumoniae isolate in association with the etest® piperacillin/tazobactam (p/t) ww s30 (ref 421166, lot 1008401840).The isolate was collected from a urine sample.Initial vitek® 2: tzp mic = 32 mg/l (resistant).Repeat vitek® 2: tzp mic = 16 mg/l (intermediate).Etest®: tzp mic = 2 mg/l (susceptible).Disk diffusion = 22 mm (susceptible).A biomérieux internal investigation has been initiated for etest® piperacillin/tazobactam (p/t) ww s30.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.Note: etest® piperacillin/tazobactam (p/t) ww s30 (ref 421166) is not registered for use in the united states.The product list tool shows the pr registration status as "onhold".However a similar product, etest® piperacillin/tazobactam (p/t) us s30 (ref 421167), is registered for use in the united states (k190154).

Manufacturer Narrative

Internal investigation (b)(4) was created to document this issue.Investigation retained samples analysis.Biomérieux retains samples of every lot numbers released to the market.The retained samples for the impacted lot number 1008401840 were tested in parallel with one internal lot number (used as reference; ref# 421166, lot 1008674580, expiry date on 19 apr 2023).The tests used quality control (qc) strains pseudomonas aeruginosa atcc® 27853¿, escherichia coli atcc® 25922¿, escherichia coli atcc® 35218¿ and klebsiella pneumoniae atcc® 700603¿.The results obtained met expected specifications for both lots tested - etest® piperacillin / tazobactam (p/t).The minimum inhibitory concentration (mic) values obtained for p.Aeruginosa atcc® 27853¿ (expected qc range : 1 ¿ 8 g/ml) were between 3 and 4 g/ml.The mic values obtained for e.Coli atcc® 25922¿ (expected qc range : 1 ¿ 4 g/ml) were between 2 and 3 g/ml.Values for e.Coli atcc® 35218¿ (expected qc range : 0,5 ¿ 2 g/ml) were between 0,75 and 1,5 ¿g/ml.Lastly, values obtained for k.Pneumoniae atcc® 700603¿ (expected qc range : 8 ¿ 32 g/ml) were between 8 and 16 g/ml.Testing customer strain as a second step, tests were performed with the klebsiella pneumoniae patient strain that the customer submitted.Identification was confirmed in-house with vitek 2 gn card as klebsiella pneumoniae ssp pneumoniae.The strain was also tested with the broth microdilution (bmd) methodology (method used for the development of etest® p/t) and with etest® p/t strips (lot numbers 1008401840 related to the complaint and 1008674580 used as reference lot).Eucast breakpoints were used to categorize the mic values [s = 8/4 r = 32/4].The following results were obtained : - bmd p/t mic obtained : > 64 g/ml (resistant); - etest® p/t mic obtained : 64 g/ml (resistant) with the lot 1008401840 related to the complaint and 32 g/ml (resistant) with the lot 1008674580 used as reference lot.Etest® p/t mic for lot number 1008401840 related to the complaint is in agreement with the reference mic without any category error.Etest® p/t mic for lot number 1008674580 used as reference lot is an essential agreement error compared to the reference mic but without any category error.The etest ® p/t susceptible results were not reproduced and no category error was observed during the investigation.Review of complaint records.On the 28th june 2021, a complaint trending analysis has been performed on the lot number 1008401840.No other complaints have been registered for this lot number.Furthermore, since 2018, it did not show any performance issue on the reference product etest® piperacillin / tazobactam (p/t), reference 421166.Conclusion.The qc results obtained in the investigation on the impacted etest® piperacillin / tazobactam (p/t) (lot number 1008401840) complied with specifications.The customer¿s susceptible results were not reproduced internally on the strain provided by the customer.Historical complaints do not show any deviations or non-conformances on the product reference etest® piperacillin / tazobactam (p/t), reference 421166.The performance of etest® ® piperacillin / tazobactam (p/t) is within specifications and as the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.

• Brand Name: ETEST PIPERACILLIN/TAZOBACTAM (P/T) WW S30
• Type of Device: ETEST® PIPERACILLIN/TAZOBACTAM (P/T) WW S30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11841835
• MDR Text Key: 281406240
• Report Number: 9615754-2021-00163
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K190154
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Catalogue Number: 421166
• Device Lot Number: 1008401840
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1