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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® IMIPENEM IP 32 WW S30

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BIOMERIEUX SA ETEST® IMIPENEM IP 32 WW S30 Back to Search Results
Catalog Number 412374
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of obtaining discrepant imipenem result for a patient klebsiella pneumoniae isolate in association with the etest® imipenem test strip (ref. 412374, lot 1006111970). The etest strip obtained a minimum inhibitory result (mic) of 2. The patient isolate was also tested using vitek 2 ® ast-n223 test kit and pcr. The vitek 2 ® ast-n223 test kit obtained a result mic
=
2 and pcr detected oxa48 a carbapenemase gene. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. Biomérieux will initiate an internal investigation.
 
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Brand NameETEST® IMIPENEM IP 32 WW S30
Type of DeviceETEST® IMIPENEM IP 32 WW S30
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme les grottes isere 383,
FR
Manufacturer (Section G)
BIOMERIEUX SA
3 route de port michaud
la balme, les grottes isere 38390
FR 38390
Manufacturer Contact
danielle cooper
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9350282
MDR Text Key220009437
Report Number9615754-2019-00125
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K913459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number412374
Device Lot Number1006111970
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 Received04/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2017
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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