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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST TRIM/SULFA TEST STRIPS ETEST® TRIM/SULFA TEST STRIPS

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BIOMERIEUX, SA ETEST TRIM/SULFA TEST STRIPS ETEST® TRIM/SULFA TEST STRIPS Back to Search Results
Catalog Number 524458
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 from the united states notified biomérieux of a potential false resistant sxt (trimethoprim/sulfamethoxazole) result in association with etest® trim/sulfa1/19 ts us f 100 test strips (ref. 524458, lot 1007246260) when testing a patient staphylococcus hominis isolate. The customer tested the staphylococcus hominis isolate using the vitek® 2 ast-gp75 test kit and etest® trim/sulfa 1/19 ts us f 100 test strips. The following results were obtained: vitek® 2 ast-gp75 (initial): sxt terminated due to "insufficient growth in positive control well". Vitek® 2 ast-gp75 (repeat): mic
=
40, susceptible. Etest®: mic
=
>8, resistant. Biomérieux completed an internal investigation regarding the susceptible vitek® 2 results. The staphylococcus hominis strain was submitted and tested using the broth micro dilution test method, and obtained a susceptible result. This result indicated the vitek® 2 ast-gp75 test kit performed as intended. The customer stated the etest® result of resistant was reported to the treating physician; however, 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. Biomérieux has initiated an internal investigation.
 
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Brand NameETEST TRIM/SULFA TEST STRIPS
Type of DeviceETEST® TRIM/SULFA TEST STRIPS
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
matthew locus
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key10101988
MDR Text Key241305492
Report Number9615754-2020-00083
Device Sequence Number1
Product Code JWY
UDI-Device Identifier03573026253271
UDI-Public03573026253271
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number524458
Device Lot Number1007246260
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 Received09/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2019
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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