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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® AMIKACIN

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BIOMERIEUX SA ETEST® AMIKACIN Back to Search Results
Model Number 412218
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A customer reported discrepant quality control results associated with etest® amikacin. The expected results with the qc organism pseudomonas aeruginosa atcc® 27853 were mic 1-4, but the actual result was mic 2-8. An investigation was performed. Testing was conducted on retained samples of the customer lot 1004907960, and in parallel with another random lot 1005011420 as a reference. Three test strips per strain and three per batch were used. Strains tested were: staphylococcus aureus atcc 29213, enterococcus faecalis atcc 29212, escherichia coli atcc 25922, pseudomonas aeruginosa atcc 27853. The four quality control strains conformed to the specifications for the lots. The customers issue was not reproduced. The problem could be linked to incubation temperature too high, incubation time too long, or the colony used. The instruction for use recommends the incubation for pseudomonas aeruginosa is 35+/-2°c between 16-20 hours.
 
Event Description
A customer in the united states notified biomérieux of discrepant quality control results associated with etest® amikacin. The customer reported the expected results with the quality control organism pseudomonas aeruginosa atcc® 27853 to be 1-4, but the actual result was 2-8. The testing was repeated. There is no indication or report from the hospital to biomérieux that the daptomycin qc failure led to any adverse event related to a patient's state of health. There is no patient directly associated with the qc sample. There may be a potential for adverse event if the event were to recur while testing a patient isolate; therefore this event is being reported as a malfunction. Culture submittals have been requested by biomérieux for internal investigation. An internal biomérieux investigation will be initiated.
 
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Brand NameETEST® AMIKACIN
Type of DeviceETEST® AMIKACIN
Manufacturer (Section D)
BIOMERIEUX SA
te, 3 route de port michaud
38390 la balme-les-grottes
FR
Manufacturer (Section G)
BIOMERIEUX SA
te, 3 route de port michaud
38390 la balme-les-grottes
FR
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6645323
MDR Text Key247161825
Report Number3002769706-2017-00137
Device Sequence Number1
Product Code JWY
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
Type of Report Initial,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2021
Device Model Number412218
Device Lot Number1004907960
Other Device ID Number03573026376567
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 Received07/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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