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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-N233 TEST KIT

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BIOMERIEUX, INC VITEK® 2 AST-N233 TEST KIT Back to Search Results
Catalog Number 413117
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 from (b)(6) notified biomérieux of some strains that initial results were resistant (r) for imipene, ertapeneme, e coli, morganella, and proteus associated with vitek® 2 ast-n233 test kit. Guidance from biomérieux to inspect product packaging, revealed puncture holes in the card foil pack. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. A biomérieux internal investigation has been initiated.
 
Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: this investigation was initiated in response to a customer complaints reporting holes in the white card pouches of some cards at the stitch seam. The root cause of the defect was linked to the design of the wheel that applies the stitch seal to the pouch. On (b)(6) 2017, stitch wheels with a new design were installed that resolve the issue. Fsca 3445 will be issued, including a customer notification with instructions for inspecting pouches prior to use in order to detect breaches and reduce the likelihood of using cards exposed to moisture. The customer letter will also explain the potential effects of moisture exposure on card performance.
 
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Brand NameVITEK® 2 AST-N233 TEST KIT
Type of DeviceVITEK® 2 AST-N233 TEST KIT
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6489474
MDR Text Key72953334
Report Number1950204-2017-00119
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K960989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/16/2018
Device Catalogue Number413117
Device Lot Number6330202103
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 Received04/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberFSCA 3445

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