• 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 AMIKACIN AK 256 US S30 ETEST® AMIKACIN AK 256 US 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 AMIKACIN AK 256 US S30 ETEST® AMIKACIN AK 256 US S30 Back to Search Results
Catalog Number 412218
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer from the united states notified biomérieux of out of range high (ooh) results in association with the etest® amikacin ak 256 us s30 (ref. 412218, lot 1007537650) when testing atcc® 27853¿ pseudomonas aeruginosa. The customer tested atcc® 27853¿ pseudomonas aeruginosa multiple times using lot 1007537650 and mueller hinton agar; each test obtained a mic value between 6-12 ¿g/ml. The etest® amikacin ak 256 us s30 instructions for use state the expected result for atcc® 27853¿ pseudomonas aeruginosa is mic between 1-4 ¿g/ml. The customer confirmed the etest® amikacin ak 256 us s30 strips were stored at -20°c and given fifteen (15) minutes to come to room temperature prior to use. Biomérieux customer service advised the customer that the etest® amikacin ak 256 us s30 strips instructions for use (ifu) handling section states to allow thirty (30) minutes for strips held at -20°c to come to room temperature prior to testing. The customer performed qc testing following the advice of biomérieux customer service; repeat testing also obtained out of range high results. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETEST AMIKACIN AK 256 US S30
Type of DeviceETEST® AMIKACIN AK 256 US S30
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
danielle cooper
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key10345325
MDR Text Key203854605
Report Number9615754-2020-00125
Device Sequence Number1
Product Code JWY
UDI-Device Identifier03573026376567
UDI-Public03573026376567
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970210
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 10/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2021
Device Catalogue Number412218
Device Lot Number1007537650
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 Received09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-