• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number 412253
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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).
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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
3 route de port michaud
la balme les grottes isere, 38390
FR 38390
MDR Report Key6682549
MDR Text Key281742563
Report Number3002769706-2017-00153
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/11/2019
Device Catalogue Number412253
Device Lot Number1005224490
Other Device ID Number03573026376710
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2017
Is This a Reprocessed and Reused Single-Use Device? No