MAUDE Adverse Event Report: BIOMÉRIEUX SA BENZYLPENICIL PG 32 WW S30 - 412265

Catalog Number 412265

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: etest® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious gram-negative and gram-positive aerobic bacteria and fastidious bacteria.The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (mic, in g/ml) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.Indications for use: etest® pg can be used to determine the mic of benzylpenicillin against the following microorganisms: streptococci (-hemolytic and viridans group).Streptococcus pneumoniae.Neisseria gonorrhoeae.Description: a customer in the netherlands notified biomérieux of receiving an etest® itraconazole it 32 ww s30 (ref 412380) strip in the packaging for etest® benzylpenicil pg 32 ww s30 (ref 412265, lot 1009823840).The customer does not order etest itraconazole it 32 ww s30 (ref 412380).The customer identified that the strip was the incorrect product after using the itraconazole strip to test the susceptibility for a patient strain of finegoldia magna.The customer was intending to test the susceptibility of this strain with etest benzylpenicil pg 32 ww s30.Due to the growth of the organism on the agar plate, a resistant result was interpreted.The customer claimed that they nearly reported the result as resistant against benzylpenicillin, but before any results were communicated to physicians, the customer realized that the strip used for testing was not benzylpenicillin and was instead itraconazole.No result related to this issue were reported to physicians.There is no indication or report from the customer that this event led to or contributed to death, serious injury, or serious deterioration in the state of health for the patient.Finegoldia magna is not a species that should be tested with either the etest benzylpenicil pg 32 ww s30 or etest itraconazole it 32 ww s30 products.The package inserts for these products list the following in the "indications for use" sections: etest benzylpenicil pg 32 ww s30: streptococci (-hemolytic and viridans group).Streptococcus pneumoniae.Neisseria gonorrhoeae.Etest itraconazole it 32 ww s30: yeasts: candida spp.Moulds: aspergillus spp.The use of these products to test finegoldia magna strains is considered to be user error / off-label use.Ref 412265 is not sold/marketed in the united states and trackit shows an fda registration status of "on hold", however an equivalent product (ref 412264) is sold/marketed in the united states and is registered with the fda (k981135).An investigation was initiated.

Manufacturer Narrative

An investigation was initiated in response to the customer complaint of receiving an etest® itraconazole it 32 ww s30 (ref 412380) strip in the packaging for etest® benzylpenicil pg 32 ww s30 (ref 412265, lot 1009823840).The customer does not order etest itraconazole it 32 ww s30 (ref 412380).Investigation: complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the customer's issue as a trend.Manufacturing investigation: the etest® benzylpenicillin (pg 32) lot number 1009823840 related to the complaint was manufactured on monday 23 jan 2023.Before the manufacturing of this etest® pg 32 lot number, an etest® itraconazole (it 32) lot was manufactured on friday 20 jan 2023.A line clearance is realized after each lot manufactured.Despite the realization of the line clearance after the manufacturing of the etest® it 32 lot, the most probably cause identified related to this issue is that an isolated it 32 strip was stuck by static electricity on the manufacturing equipment.This it 32 strip was taken down during the manufacturing of the etest® pg 32 lot number 1009823840 and was integrated in a blister of this etest® pg 32 lot number.Conclusion: the manufacturing investigation concluded to an isolated issue despite the line clearance applied after each manufacturing of etest® lots.An improvement of the manufacturing process is currently in progress which will have a positive impact to avoid the static electricity.The complaint trend analysis does not show any negative trend for etest® products related to this type of issue.

• Brand Name: BENZYLPENICIL PG 32 WW S30 - 412265
• Type of Device: BENZYLPENICIL PG 32 WW S30 - 412265
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 17346411
• MDR Text Key: 319419732
• Report Number: 9615754-2023-00034
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K981135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412265
• Device Lot Number: 1009823840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1