MAUDE Adverse Event Report: BIOMERIEUX SA LYFOCULTS® PLUS CANDIDA KRUSEI

Catalog Number 300959

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2015, a customer contacted biomerieux to report a discrepant results when using product lyfocults plus candida krusei during an internal quality control test.The customer stated the mic, minimum inhibitory concentration range, of the amphotericina b was:<0,25 and the expected range was 0,50< 2.00.The customer stated that retesting was performed on the subject strain using two different vitek 2 systems; anomalies were noted on both systems qc results.There are no issues with other strains of candida species or testing process; operated correctly all stages of sample preparation including controls on sterility.No patient results were affected or delayed results reported.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The customer's qc strain and the in-house qc strain were sub-cultured and amphotericin b testing included two (2) ast-ys07 cards from the same lot as that tested by the customer and two (2) cards from a random lot.All ast-ys07 cards tested for each qc strain provided acceptable mics = 0.5 or 1.The vitek ast-ys07 cards are performing in accordance with specifications.

• Brand Name: LYFOCULTS® PLUS CANDIDA KRUSEI
• Type of Device: LYFOCULTS® PLUS CANDIDA KRUSEI
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5285950
• MDR Text Key: 33940444
• Report Number: 3002769706-2015-00164
• Device Sequence Number: 1
• Product Code: JTR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: CL I, EXEMPT
• 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: 11/15/2015

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 Date: 11/02/2016
• Device Catalogue Number: 300959
• Device Lot Number: 1003575250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1