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

MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® ERTAPENEM ETP 32 WW B30

  • 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
 

BIOMERIEUX, SA ETEST® ERTAPENEM ETP 32 WW B30 Back to Search Results
Catalog Number 531600
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Biomérieux conducted an internal investigation: this investigation was initiated due to a discrepancy between etest® etp 32 (ertapenem) reference 531600 blister, result of susceptible(s) obtained by the customer and the expected result by the neqas survey resistant(r/i ). The strain is an enterobacter cloacae complex neqas # (b)(4). During identification testing, testing confirmed result of enterobacter cloacae on vitek® 2 gn card. Clsi 2017 breakpoints enterobacteriaceae -ertapenem [ s less than or equal to 0. 5 - 1 - greater than or equal to 2 r ]. Eucast 2017 breakpoints enterobacteriaceae -ertapenem [ s less than or equal to 0. 5 - > 1 r ]. · reference method used for etest® development: agar dilution (ad) : etp mic
=
0. 5 mg/l : s. · reference method recommended by neqas : broth microdilution (bmd) : etp mic
=
1 mg/l : i. · mechanism of resistance detection: pcr imp, oxa48 like, kpc, ndm and vim negative (essay msast-465). ·a reproducibility study was performed on etest®. All qc strains were conform (pseudomonas aeruginosa atcc 27853, escherichia coli atcc 25922, staphylococcus aureus atcc 29213, enterococcus faecalis atcc 29212, bacteroides fragilis atcc 25285, streptococcus pneumoniae atcc 49619, haemophilus influenzae atcc 49766) and the neqas strain gave mic equal to 0. 5 mg/l s. Biomérieux reproduced the customer results of susceptible (s). Etest® etp (mic 0. 5 ¿g/ml s) is an essential agreement with the reference mic 0. 5 mg/l obtained with agar dilution (method used for the development of etest etp strip ) , without category error. Etest® etp strip performed as intended, and no further action is required. The broth microdilution which is the method used by neqas, was also performed. It gave an etp mic equal to 1 mg/l i. This result is in the middle of the clsi breakpoints, so within 1 doubling dilution the category can be s or r.
 
Event Description
A customer from (b)(6) reported to biomérieux a false susceptible ertapenem result for an external quality control sample (nequas 3419) in association with etest® ertapenem etp 32 ww b30. The customer reported that the result of the etest® was sensitive (mic 0. 5) several times. The expected result was intermediate or resistant and the customer stated that disk diffusion gave the correct result. A biomerieux investigation will be initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETEST® ERTAPENEM ETP 32 WW B30
Type of DeviceETEST® ERTAPENEM ETP 32 WW B30
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme les grottes isere, 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme les grottes isere, 38390
FR 38390
Manufacturer Contact
ellen weltmer
595 anglum road
st. louis, MO 63042
3147317301
MDR Report Key6354960
MDR Text Key192867351
Report Number3002769706-2017-00036
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K020748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue Number531600
Device Lot Number1003530750
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2014
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-