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U.S. Department of Health and Human Services

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

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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
A customer from austria reported to biomérieux a false susceptible ertapenem result for an enterobacter cloacae complex, external quality control sample ((b)(4)), in association with etest® ertapenem etp 32 ww. An investigation was performed. The sample identification was confirmed as enterobacter cloacae with the vitek® 2 gn card. Susceptibility testing included the use of: clsi 2017 breakpoints enterobacteriaceae -ertapenem [ s =
0. 5 - 1 - >/
=
2 r ]. Eucast 2017 breakpoints enterobacteriaceae -ertapenem [ s =
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 with the etest customer lot and a reference lot, and the customer result (s) was reproduced. All qc strains (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) were conforming and the neqas strain gave mic equal to 0. 5 mg/l s. 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. In conclusion , the customer's susceptible result with etest etp was duplicated. The etest etp (mic 0. 5 ;g/ml s) is in 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. The etest etp strip performed as intended, and no further action is required.
 
Event Description
A customer from austria reported to biomérieux a false susceptible ertapenem result for an enterobacter cloacae complex, external quality control sample ((b)(4)), in association with etest® ertapenem etp 32 ww b30. The customer reported the etest® result was out of range low (mic 0. 5 ug/ml) and the expected result was resistant (mic >
=
2 ug/ml). The sample was tested with vitek® 2 and the result was mic 2 ug/ml. Testing with the disc method produced a result of 20 mm. As the issue occurred during external quality control testing, there was no patient involvement. A biomérieux internal investigation will be initiated.
 
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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 Key6443992
MDR Text Key192881759
Report Number3002769706-2017-00057
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeAU
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 Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2017
Device Catalogue Number531600
Device Lot Number1003569060
Other Device ID Number03573026249380
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 Manufactured11/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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