MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® BENZYLPENICIL PG 32 US S30

Catalog Number	412264
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomerieux 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 s30 (ref.(b)(4), lot 1007645640).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 there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomerieux internal investigation has been initiated.
Additional 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 s30 (ref.412264, lot 1007645640).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 s30 (reference 412264).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 investigation.As the investigation did not identify a 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 S30
• Common Device Name: ETEST® BENZYLPENICIL PG 32 US S30
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme ; FR
• MDR Report Key: 9890707
• Report Number: 9615754-2020-00056
• Device Sequence Number: 19628980
• Product Code: JWY
• UDI-Device Identifier: 03573026376826
• UDI-Public: 03573026376826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K981135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: 412264
• Device Lot Number: 1007645640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1