• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • 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
 

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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of false susceptible meropenem results for enterobacter cloacae complex in association with the etest® meropenem mp 32 ww b30 (ref 513800, lot 1007496370). The isolate was collected from a patient urine specimen. Initial testing with the etest® meropenem mp 32 ww b30 obtained a meropenem mic
=
2 mg/l (susceptible). The strain was also tested with the vitek® 2 ast-n248 test kit and the vitek® 2 ast-n387 test kit. Both vitek® 2 tests obtained the same result of mic > 8 mg/l (resistant). Agar diffusion testing was also performed as an alternative method and obtained a resistant result of d
=
15 mm (resistant). Polymerase chain reaction (pcr) testing indicated that the strain was a carbapenem-resistant strain. The customer indicated that the false susceptible etest® result was not reported to the physician. There is no indication or report from the laboratory that this event led to any adverse event related to the patient's state of health. A biomérieux internal investigation will be initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
matthew locus
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9920460
MDR Text Key225600313
Report Number9615754-2020-00059
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeGM
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 07/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/17/2022
Device Catalogue Number513800
Device Lot Number1007496370
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 Received06/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-