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

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.

• Brand Name: VITEK® 2 AST-N233 TEST KIT
• Type of Device: VITEK® 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 Key: 6489474
• MDR Text Key: 72953334
• Report Number: 1950204-2017-00119
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K960989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2018
• Device Catalogue Number: 413117
• Device Lot Number: 6330202103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FSCA 3445
• Patient Sequence Number: 1