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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® MEROPENEM MP 32 WW B30

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BIOMERIEUX SA ETEST® MEROPENEM MP 32 WW B30 Back to Search Results
Catalog Number 513800
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 meropenem results for three (3) separate patient isolates in association with the etest® meropenem test strip (ref. 513800, lot 1007278480). The patient isolates were also testing via vitek® 2 ast-n233 test kit and pcr. The summary of results is listed below. Patient 2: strain id - kelbsiella oxytoca. Vitek® ast-n233 result - mic >8, resistant. Etest® result - mic
=
0. 38 susceptible. Pcr result - carbapenemase vim detected, resistant. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. Biomérieux will initiate an internal investigation.
 
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Brand NameETEST® MEROPENEM MP 32 WW B30
Type of DeviceETEST® MEROPENEM MP 32 WW B30
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 Key9350499
MDR Text Key220258767
Report Number9615754-2019-00127
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 Expiration Date03/31/2022
Device Catalogue Number513800
Device Lot Number1007278480
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 Manufactured04/12/2019
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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