MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® BENZYLPENICIL PG 32 US F100; BENZYLPENICIL PG 32 US F100 - 502658

Catalog Number 502658

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of out-of-range high benzylpenicillin results for enterococcus faecalis atcc® 29212¿ when performing internal quality control testing with the etest® benzylpenicil pg 32 us f100 (ref 502658, lot 1007477190).The customer obtained a mic of 32 mg/l (resistant) and the expected range for enterococcus faecalis atcc® 29212¿ is 1 - 4 mg/l (susceptible).As the customer was performing internal qc testing, there is no patient involved.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states regarding out-of-range high benzylpenicillin results for enterococcus faecalis atcc® 29212¿ when performing internal quality control testing with the etest® benzylpenicil pg 32 us f100 (ref 502658, lot 1007477190).Multiple quality control strains tested on the retained samples of the impacted etest pg 32 lot complied with specifications; however, out-of-range high results were observed for enterococcus faecalis atcc 29212 depending on the mueller hinton medium supplier used.Per the package insert, a quality control test must be performed to validate the quality of the medium in use.The trend analysis for the complaint topic does not show any deviation on the product reference etest benzylpenicillin pg 32 us f100 (reference 502658).Since 2010, four (4) other complaints have been registered for out of range results on etest pg 32 with enterococcus faecalis atcc 29212.These complaints were isolated events solved without investigations.As the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.Complaint trend analysis for the referenced product will continue to be monitored.

• Brand Name: ETEST® BENZYLPENICIL PG 32 US F100
• Type of Device: BENZYLPENICIL PG 32 US F100 - 502658
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme ; FR
• MDR Report Key: 9888194
• MDR Text Key: 208194892
• Report Number: 9615754-2020-00054
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026252465
• UDI-Public: 03573026252465
• Combination Product (y/n): N
• PMA/PMN Number: K981135
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Catalogue Number: 502658
• Device Lot Number: 1007477190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1