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U.S. Department of Health and Human Services

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

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BIOMÉRIEUX, SA ETEST MEROPENEM MP 32 WW B30 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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Note: ref 513800 is not registered with the fda for use in the united states. However, a similar product, ref 513840, is registered with the fda for use in the united states (k010363). A customer in (b)(6) notified biomrieux of discrepant results in association with etest meropenem 32 ww b30 test strips (ref. 513800 lot 1007878210). The customer initially tested a patient klebsiella pneumoniae strain using both etest lot 1007878210 and vitek 2 test methods. Vitek 2 obtained a meropenem minimum inhibitory concentration (mic) of
=
16 g/ml. Etest lot 1007878210 obtained a mic 0. 38 g/ml. After obtaining the discrepant mic 0. 38 g/ml result, the customer performed quality control (qc) testing on lot 1007878210 using escherichia coli atcc 25922" and pseudomonas aeruginosa atcc 27853". Abnormal ellipses were observed for both organisms and a mic was unable to be determined for either organism. The patient klebsiella pneumoniae strain was then tested using a different etest lot, a resistant mic
=
32 g/ml was obtained, which aligned with the vitek 2 result. 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. Biomerieux has initiated 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)
BIOMÉRIEUX, SA
3 route de port michaud
la balme 39390
FR 39390
Manufacturer (Section G)
BIOMÉRIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
jennifer schmatz
595 anglum road
hazelwood, MO 63042
MDR Report Key11345035
MDR Text Key243657018
Report Number9615754-2021-00017
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K010363
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 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number513800
Device Lot Number1007878210
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 Received07/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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