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

Catalog Number 412265

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer.

Event Description

Biomerieux initiated an internal complaint for etest® benzylpenicil pg 32 ww s30 strips (ref.412265) following the issuance of a warning letter from the (b)(4).(b)(4) investigated the accuracy of benzylpenicillin gradient test, which included biomérieux etest® benzylpenicil pg 32 ww s30 (ref 412265).The gradient tests were tested on in-house prepared mueller hinton fastidious agar from oxoid (thermo fisher scientific) and bbl (bd).Broth microdilution using mueller-hinton-f (mh-f) broth was used as the reference.(b)(4) concluded that the available gradient tests (including etest®) systematically underestimate benzylpenicillin mic values in streptococcus pneumoniae when compared to the broth microdilution reference method.As there is no patient associated with this (b)(4) study, there is no adverse event related to any patient's state of health.Biomerieux has initiated an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to an internal complaint for etest® benzylpenicil pg 32 ww s30 strips (ref.412265) following the issuance of a warning letter from the european committee on antimicrobial susceptibility testing (eucast).Performance study: an internal performance study was carried out on etest pg32 strip with 33 strains of streptococcus pneumoniae (mic between 0.5 and 4 mg/l).This study shows an underestimation of etest pg 32 mics compared to the reference method: broth micro dilution (bmd) eucast (version 2019).This underestimation remains acceptable because the mic agreement rate is higher than 90% (iso criteria: ea = 90%).Complaint trend analysis: the trend analysis of the complaints does not show any deviation on the reference product etest pg32 strips.Conclusion: the eucast statement on etest pg32 mics underestimation has been reproduced with the internal set of strains tested, however, the internal performance study demonstrates that etest pg32 remains with its expected specifications (mic agreement rate is higher than 90%).See h10 for addtl mfg narrative.

• Brand Name: ETEST® BENZYLPENICIL PG 32 WW S30 - 412265
• Type of Device: ETEST® BENZYLPENICIL PG 32 WW S30 - 412265
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 9505726
• MDR Text Key: 217724317
• Report Number: 9615754-2019-00141
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412265
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1