MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® AMIKACIN

Model Number 412218

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.

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.

• Brand Name: ETEST® AMIKACIN
• Type of Device: ETEST® 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 Key: 6645323
• MDR Text Key: 77845874
• Report Number: 3002769706-2017-00137
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Model Number: 412218
• Device Lot Number: 1004907960
• Other Device ID Number: 03573026376567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1