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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® ITRACONAZOLE

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BIOMERIEUX SA ETEST® ITRACONAZOLE Back to Search Results
Catalog Number 525858
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in the united states notified biomérieux of out of range low results for internal quality controls (qc) in association with etest® itraconazole (reference 525858).The customer reported that at 24 hours they had a mic value of 0.016 on multiple test strips.At 48 hours the customer reported test results of 0.032.The customer has tested the same lot of strips with multiple lots of organisms and media.The customer ordered another order of strips, and received the same lot.They tested the new kit of etest® strips and received similar results.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
A customer in the united states notified biomérieux of out of range low results for internal quality control (qc) strain candida albicans (atcc 90028) in association with etest® itraconazole (reference (b)(4)).An mic value of 0.032 g/ml was obtained for an expected mic value range of 0.064-0.25 g/ml.An internal biomérieux investigation was performed.Retained sample analysis: the conformity of the lot reported, 1005507630, and a reference lot 1005871860 used during the investigation, were confirmed with the atcc quality control strains tested for the release of this reference: atcc (b)(6) candida parapsilosis, atcc (b)(6) candida krusei, atcc (b)(6) candida albicans.Complaints trend analysis: no other complaint was registered on this lot.The trend analysis was reviewed and did not indicate any issues with this product.Conclusion: the results obtained with the atcc quality control strains tested during this investigation conformed with the product specifications.No other complaints were registered on this lot number and the trend analysis of the complaints does not show any problem on this reference.No further actions were deemed necessary.
 
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Brand Name
ETEST® ITRACONAZOLE
Type of Device
ETEST® ITRACONAZOLE
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme les grottes isere 383,
FR 
MDR Report Key7620578
MDR Text Key112571794
Report Number3002769706-2018-00086
Device Sequence Number1
Product Code NGZ
UDI-Device Identifier03573026253318
UDI-Public03573026253318
Combination Product (y/n)N
PMA/PMN Number
K040560
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 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2020
Device Catalogue Number525858
Device Lot Number1005507630
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/20/2018
Supplement Dates Manufacturer Received07/24/2018
Supplement Dates FDA Received08/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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