• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® CEFTAZIDIME TZ 256 WW S30

  • 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
 

BIOMERIEUX SA ETEST® CEFTAZIDIME TZ 256 WW S30 Back to Search Results
Catalog Number 412293
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) reported false susceptible ceftazidime (caz) results for a pseudomonas aeruginosa (atcc 27853) quality control strain, and a pseudomonas strain isolated from a patient in intensive care, in association with the etest® ceftazidime tz 256 ww s30 (lot 1005376560). The customer stated that the caz value for the qc strain was mic
=
0. 5mg/l (out of range low) instead of mic
=
1-4 mg /l. A new qc strain was tested and the result was the same, mic
=
0. 5mg/l. The patient strain was tested twice on the impacted lot and the result was caz mic
=
4mg/l. The customer also performed the broth micro dilution method and a different i2a ast test on the impacted patient strain, and obtained correlated results of mic
=
16 mg/l (resistant result). The customer stated that the false result had a clinical impact on the patient, but no additional information was provided. A biomérieux internal investigation will be initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETEST® CEFTAZIDIME TZ 256 WW S30
Type of DeviceETEST® CEFTAZIDIME TZ 256 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 383
FR
Manufacturer Contact
debra broyles
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key7504475
MDR Text Key108616790
Report Number3002769706-2018-00065
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K971694
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 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/15/2018
Device Catalogue Number412293
Device Lot Number1005376560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-