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U.S. Department of Health and Human Services

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

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BIOMERIEUX SA ETEST® CEFTAZIDIME TZ 256 WW S30 Back to Search Results
Catalog Number 412293
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)(4) reported a false susceptible ceftazidime result for a patient strain of pseudomonas aeruginosa while using etest® ceftazidime (tz) strips (reference 412293, lot 1006985220). The etest® ceftazidime strips obtained a minimum inhibitory concentration (mic) of 6-8g/ml (susceptible). The customer then tested the isolate using etest tz strips in duplicate, liofilchem® ceftazidime strips, and liofilchem ceftazidime/avibactam strips. All assays obtained a mic of 12g/ml (resistant). The customer confirmed the susceptible ceftazidime result was given to the treating physician; however, the biologist advised against its use. The following antibiotic therapies were prescribed to the patient: (b)(6) 2019: piperacilline + tazobactam, cotrimoxazole, valaciclovir. (b)(6) 2019: ciprofloxacine, ceftazidime-avibactam then ceftazidime, fosfomycine and amikacine. (b)(6) 2019: ceftolozane + tazobactam, ciprofloxacine, caspofungine and metronidazole. The customer also stated, "patient is dead but it's not because of the results she gave to the clinician, the patient has aplasia, digestive complications, and severe sepsis. " the patient isolate was sent to a reference lab and tested again forceftazidime, cetolozane/tazobactam and ceftazidime/avibactam. The results obtained were: mic
=
168g/ml (resistant), mic
=
28g/ml (susceptible), and mic
=
168g/ml (resistant). Biomérieux has requested further information regarding the patient treatment effectiveness. Based on the current available information, there is no indication or report from the laboratory that the discrepant result had any adverse impact on the patient's state of health. Biomérieux has initiated an internal investigation.
 
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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
candace martin
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9159281
MDR Text Key220017196
Report Number9615754-2019-00096
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/10/2020
Device Catalogue Number412293
Device Lot Number1006985220
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 Received11/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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