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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

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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 in the united states notified biomérieux of obtaining out of range high results while testing a pseudomonas aeruginosa atcc® 27853¿ strain using the etest® strip amikacin 256 (reference # 412218, lot # 1007980340). Etest® results: expected range: 1-4 ¿g/ml. Obtained: 8 ¿g/ml. The customer reported that the strip was tested with e. Coli atcc and received passing results. There is no patient associated with this qc isolate; therefore, there is no adverse event related to any patient's state of health. A biomérieux internal investigation has been initiated.
 
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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
MDR Report Key10468878
MDR Text Key234605826
Report Number9615754-2020-00141
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 Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2022
Device Catalogue Number412218
Device Lot Number1007980340
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 Manufactured04/01/2020
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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