MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® AMPICILLIN AM 256 WW S30

Catalog Number 412253

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomerieux false susceptible ampicillin results in association with etest® ampicillin am 256 ww s30.The customer reported that they compared results of patient enterococcus faecalis strains for etest® and disk diffusion methods.The customer stated that ten (10) strains of the forty-one (41) tested were susceptible with etest® ampicillin and resistant with disk diffusion.The internal qc (e.Faecalis atcc 29212) for disk diffusion was in the range according to eucast but outside for etest® (0.38mg/l for a target 0.5 - 2.0).The customer reported that patient results were not affected as disk diffusion was used as first line and there was no report of patient treatment being affected.There was no delay for reporting patient results.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) had reported to biomérieux false susceptible results on 10 strains of enterococcus faecalis with etest® ampicillin am 256 s30 (ref 412253, lot 1005224490), while these strains are resistant (eight strains) or intermediate (two strains) with disk diffusion (eucast break points).The customer tested for beta-lactamase, and all strains were cefinase negative.An internal biomérieux investigation was performed.The customer did not keep any of the strains to submit for further evaluation.The customer results on qc strain enterococcus faecalis atcc 29212 are compliant: mic=0.38 mcg/ml for a range of 0.5-2 mcg/ml.As explained on the quality control procedure, mic results for a quality control strain that fall a half dilution below the lower qc limit should be rounded up to the next upper two-fold value before establishing qc compliance.We conducted an investigation on retained samples corresponding to the batch 1005224490 (customer lot) in parallel with another batch as a reference on quality control strains.The conformity of this batch was confirmed with all qc strains: staphylococcus aureus atcc 29213, enterococcus faecalis atcc 29212, escherichia coli atcc 25922, haemophilus influenzae atcc 49247 and enterococcus faecium cap d5.We carried out a complementary investigation on 13 clinical enterococcus faecalis strains.The 13 strains of enterococcus faecalis tested in this study are susceptible to ampicillin with the etest method and disk diffusion method (ampicillin 2 mcg: eucast method).With the cefinase test, 11 out of 13 strains are cefinase positive and possess a beta-lactamase.Ampicillin resistant strains in diffusion disk and without beta-lactamase identical to the strains of the customer were not found internally.We never registered complaints on this drug for this problem in the past.In conclusion, the customer problem has not been reproduced.In this study, the categorizations are identical between etest am and the disk diffusion method (ampicillin 2 mcg: eucast method).However, 11 tested strains had a beta-lactamase but did not have a modification of the pbp, as the issue strains from the customer had.Having no strains of enterococcus faecalis with modification of the pbp and resistant with disk diffusion method in biomérieux's strain collection, further investigations are impossible.According to a publication (pathology.2014 oct;46(6):544-50.Doi: 10.1097/pat.0000000000000146), etest ampicillin is well correlated with the reference method: bmd (ca = 100%) and disk diffusion method: disk 10 mcg (ca = 100 %) for ampicillin-sensitive enterococcus faecalis, which are resistant to penicillin g and do not have beta-lactamase (following the clsi guide).

• Brand Name: ETEST® AMPICILLIN AM 256 WW S30
• Type of Device: ETEST® AMPICILLIN
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 6682549
• MDR Text Key: 78984405
• Report Number: 3002769706-2017-00153
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K913459
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2019
• Device Catalogue Number: 412253
• Device Lot Number: 1005224490
• Other Device ID Number: 03573026376710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1