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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA TOBRAMYCIN TM 256 US S30

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BIOMERIEUX, SA TOBRAMYCIN TM 256 US S30 Back to Search Results
Catalog Number 412478
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Intended use: etest® is a quantitative technique for determining the antimicrobial susceptibility of gram-negative and gram-positive aerobic bacteria such as enterobacteriacaea, pseudomonas, staphylococcus and enterococcus species and fastidious bacteria, such as anaerobes, n. Gonorrhoeae, s. Pneumoniae, steptococcus and haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (mic), in ¿g/ml, of different antimicrobial agents against microorganisms as tested on agar medium using overnight incubation. Description of the issue: a customer in united states notified biomérieux of obtaining out-of-range-low results on quality strain enterococcus faecalis atcc® 29212¿ when using the etest® tobramycin tm 256 us s30 - reference 412478 - lot #1007859110 - expiration date: 30/01/2022. The customer obtained tobramycin mic
=
4 ug/ml while the expected range for this qc strain is from 8 ug/ml to 32ug/ml. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. A biomérieux internal investigation will be initiated.
 
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Brand NameTOBRAMYCIN TM 256 US S30
Type of DeviceTOBRAMYCIN TM 256 US S30
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
MDR Report Key11866572
MDR Text Key281408975
Report Number9615754-2021-00166
Device Sequence Number1
Product Code JWY
UDI-Device Identifier03573026378875
UDI-Public03573026378875
Combination Product (y/n)N
PMA/PMN Number
K102668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2022
Device Catalogue Number412478
Device Lot Number1007859110
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

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