MAUDE Adverse Event Report: BIOMÉRIEUX, SA ETEST BENZYLPENICIL PG 32 WW S30 - 412265; ETEST® BENZYLPENICIL PG 32 WW S30 - 412265

Catalog Number 412265

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 client from (b)(6) notified biomérieux that he has an issue with etest® benzylpenicil pg 32 ww s30 product (ref.412265, lot 1007645670).For two (2) successive quality control tests, which the client does one time per week, using the quality strain staphylococcus aureus atcc® 29213¿, the result was out of range low with etest benzylpenicillin pg 32 ww s30 product.The client obtained 0.016 g/ml and 0.047 g/ml which is lower than the acceptable range: [0.25 ¿ 2 g/ml] for s.Aureus atcc® 29213¿ toward benzylpenicillin.The out of range low results correspond to a change in interpretation (false susceptible).As it was quality control test, there was no patient sample involved.A biomérieux internal investigation will be initiated.Note: benzylpenicil pg 32 ww s30 - 412265 is not registered for use in the united states.However a similar product, benzylpenicil pg 32 us s30 - 412264, is registered for use in the united states (k981135).

Manufacturer Narrative

An internal investigation was initiated in response to a customer complaint of out of range low results for staphylococcus aureus atcc® 29213¿ with etest benzylpenicillin pg 32 ww s30 product (ref.412265, lot 1008126430).The out of range low result corresponds to a change in interpretation (false susceptible).---complaint trend analysis--- complaint trending analysis did not identify this issue as a trend for this lot or this product.---batch record analysis--- no observations or non-conformities were identified during manufacturing and quality control for this lot.---investigational testing--- quality control strains were tested using retain samples of the customer's lot (1008126430) and a reference lot (1007452230).Three strips per etest lot, per strain were tested.Tested strains: - bacteroides fragilis atcc 25285 cq 161 - staphylococcus aureus atcc 29213 cq 129 - staphylococcus aureus atcc 25923 cq 140 - neisseria gonorrhoeae atcc 49226 cq 246 - streptococcus pneumoniae atcc 49619 cq 221 - escherichia coli atcc 25922 cq 126 - enterococcus faecalis atcc 29212 cq 147 results: all results obtained during investigational testing were within the expected ranges for quality control testing.Specifically, all investigational testing results for staphylococcus aureus atcc 29213 were mic = 0.38 ¿g/ml.Staphylococcus aureus atcc 29213 (qc specifications : 0.19 - 1 ¿g/ml) - customer's lot 1008126430 : 0.38 ¿g/ml - reference lot 1007452230 : 0.38 ¿g/ml ---conclusion--- the cause for the customer's reported out of range low results could not be established.The customer's issue of out of range low results for staphylococcus aureus atcc 29213 was not reproduced internally.The product is performing as intended.

• Brand Name: ETEST BENZYLPENICIL PG 32 WW S30 - 412265
• Type of Device: ETEST® BENZYLPENICIL PG 32 WW S30 - 412265
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11569146
• MDR Text Key: 272975630
• Report Number: 9615754-2021-00037
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K981135
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: 412265
• Device Lot Number: 1007645670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1