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

Catalog Number 412265

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported discrepant results in association with the etest® benzylpenicil pg 32 ww s30 (lot 1005602990), when compared to their reference lab results.The customer stated that the discrepant results involved patient isolates and that quality control strains had no problems.The customer reported that they are seeing a high discrepancy rate for isolates that are at the penicillin meninigitis break point (i.E.0.06) or higher.The customer confirmed the patient results were delayed and also erroneous results were reported to the physician.The customer stated they would not provide patient details at this time.The customer stated they are testing in house and sending to a reference lab, so erroneous results would have been amended within a few days.There is no indication or report from the hospital or treating physician to biomérieux that any discrepant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A biomérieux internal investigation was performed for a customer in canada reporting discrepant minimum inhibitory concentration (mic) results with several streptococcus pneumoniae strains when using etest® benzylpenicil pg 32 ww s30 (reference 412265) when compared to the broth micro dilution (bmd) method.The customer reported the issue occurred with five (5) lots (1005602990, 1005703390, 1005722590, 1005850850 and 1006304190).A results review showed there were seven (7) strains from three (3) patients with mic values having a difference of two (2) dilutions between etest pg 32 and sensitive bmd.There were three (3) strain mic values with a difference of only one dilution between the two methods.These results were considered acceptable.Quality control (qc) results conformed with quality control strain streptococcus pneumoniae atcc 49619 and etest pg 32.1.Retained samples analysis the conformity of the lots 1005602990, 1005703390, 1005722590, 1005850850 and an internal reference lot 1006573120 used for the investigation, were confirmed with all atcc quality control strains tested for the release of the product.The last lot 1006304190 was received at a later date, and only atcc 49619 streptococcus pneumoniae was tested and the result was consistent.2.Testing on customer strains received the customer submitted five (5) strains for evaluation in which the mic values obtained presented a difference of two (2) dilutions between etest pg 32 and sensitive bmd.Identification of the strains received were confirmed with vitek® ms.Four (4) strains were identified as streptococcus pneumoniae.One strain was streptococcus mitis/oralis.All five (5) strains were tested with the five (5) lots of etest pg 32 lots and an etest pg 32 reference lot.The bmd method, which is the reference method used for the development of the etest pg 32 strip, was also tested in parallel with the five strains.Results obtained with bmd: s1: 4 mg/l => r s2: 4 mg/l => r s3: 2 mg/l => r s4: 8 mg/l => r s5: 1 mg/l => i.Results obtained with etest pg 32: s1: 2 mg/l on all lots except for lot 1005703390 (4mg/l)=> r s2: 2 mg/l on all lots => i s3: 1 mg/l on all lot=>i except for lot 1006781930 (2 mg/l)=> r s4: 8 mg/l on all lots => r s5: 1 mg/l on all lots => i.Following clinical context , the breakpoints used can be different for s.Pneumoniae strains :using penicillin (parenteral-non meningitidis) breakpoints: no error of category on the 3 strains (s3/s4/s5) and only presence of minor error of category for the the strain s1.Using penicillin (parenteral - meningitidis) breakpoints: no error of category.3.Complaints trend analysis no other complaint was registered for this type of problem for all the etest pg 32 lots.4.Conclusion the results obtained with the atcc quality control strains tested during the investigation conformed with specifications.The issue was not reproduced on the retained samples tested.The etest pg 32 mic values obtained are within essential agreement when compared to the mic values obtained with the bmd reference method for all five patient strains tested.The trend analysis of the complaints does not show any problem on this reference.Note: as penicillin is a beta-lactam, the reading must be done with bactericidal mode.The etest pg mic must be read at complete inhibition of growth where the ellipse intersect the strip.

• Brand Name: ETEST® BENZYLPENICIL PG 32 WW S30
• Type of Device: ETEST® BENZYLPENICIL PG 32 WW S30
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383, ; FR
• MDR Report Key: 7619776
• MDR Text Key: 112445061
• Report Number: 3002769706-2018-00080
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Catalogue Number: 412265
• Device Lot Number: 1005602990
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2018
• Patient Sequence Number: 1