MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-YS08 TEST KIT.

Catalog Number 420739

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the (b)(6) reported to biomérieux an out of range low (oorl) fluconazole result for a candida krusei quality control strain (atcc 62058), in association with the vitek® 2 ast-ys08 test kit.The customer tested the strain twice, by using the ast-ys08 card on two different instruments.The result was mic = 4 for both tests with the expected range of mic 8 >/= 64.There was no patient involvement as the event pertained to a quality control sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the (b)(6) reported to biomérieux an out of range low (oorl) fluconazole (flu) result for a candida krusei quality control strain (atcc 62058), in association with the vitek® 2 ast-ys08 test kit.The customer submitted the strain and cards for evaluation.An investigation was performed.On vtek 2 (v7.01), tests were performed with two c.Krusei atcc 6258 strains (internal reference strain and customer strain), from sda subcultured under aerobic atmosphere as recommended.Two (2) ast-ys08 cards lots which included the customer lot (2880150203) and random lot (2880297203) were tested in duplicate.The flu results were mic = 8 mg/l for both lots and with both strains tested.The customer issue was not duplicated.The vitek 2 ast-ys08 card performed as intended and no further action is required.

• Brand Name: VITEK® 2 AST-YS08 TEST KIT.
• Type of Device: VITEK® 2 AST-YS08 TEST KIT.
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7125873
• MDR Text Key: 96024208
• Report Number: 1950204-2017-00461
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K061945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2018
• Device Catalogue Number: 420739
• Device Lot Number: 2880150203
• Other Device ID Number: 03573026535353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1