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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST CEFTRIAXONE TX 32 WW S30 ETEST® CEFTRIAXONE TX 32 WW S30

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BIOMERIEUX SA ETEST CEFTRIAXONE TX 32 WW S30 ETEST® CEFTRIAXONE TX 32 WW S30 Back to Search Results
Catalog Number 412303
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 resistant ceftriaxone results when testing a streptococcus anginosus strain with etest® ceftriaxone tx 32 ww s30 (ref 412303, lot 1007439280, expiry date 30-jun-2020). Etest test 1 (lot 1007439280): ceftriaxone mic
=
1 mg/l (resistant); etest test 2 (lot 1007439280): ceftriaxone mic
=
1 mg/l (resistant); etest test 3 (lot 1007702120 ): ceftriaxone mic
=
0. 5 mg/l (susceptible). The resistant results were initially reported to the physician. The physician received the ceftriaxone resistant results and changed the patient's treatment from ceftriaxone to tavanic. After the physician received the final test result of ceftriaxone susceptible, treatment with ceftriaxone was resumed. There is no indication or report from the customer that the false resistant result and antibiotic treatment changes led to any adverse event related to the patient's state of health. A biomérieux internal investigation has been initiated. Note: reference 412303 is not registered in the united states. The u. S. Similar device is product reference 412302.
 
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Brand NameETEST CEFTRIAXONE TX 32 WW S30
Type of DeviceETEST® CEFTRIAXONE TX 32 WW S30
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme
FR
Manufacturer (Section G)
BIOMERIEUX SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
danielle cooper
595 anglum road
hazelwood, MO 63042
MDR Report Key10220974
MDR Text Key241355057
Report Number9615754-2020-00109
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K981139
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 11/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number412303
Device Lot Number1007439280
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 Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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