MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS MYCOB/NOCARDIA KIT

Model Number VITEK® MS MYCOBACTERIUM/NOCARDIA KIT

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining a misidentification of rhizopus arrhizus as aspergillus terreus complex in association with the vitek® ms (ref 410895) and the vitek® ms mycobacterium/nocardia kit (ref 415659).The customer indicated that sometimes they have issues with obtaining identifications for rhizopus arrhizus and cryptococcus curvatus strains, and stated that they had obtained a misidentification of a rhizopus arrhizus strain as aspergillus terreus complex.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.Biomérieux initiated an internal investigation for this report.

Manufacturer Narrative

A customer in russia notified biomérieux of obtaining a misidentification of rhizopus arrhizus as aspergillus terreus complex in association with the vitek® ms (ref (b)(4)) and the vitek® ms mycobacterium/nocardia kit (ref (b)(4)).On 07 dec 2021, the biomérieux investigator requested data and information regarding this report.Additional requests were made on 17dec2021, 03jan2022 and 24jan2022.The investigator did not receive a response.Without additional information (i.E.Customer raw data, fine tuning details, reference identification method) no investigation can be conducted.The investigator notified biomérieux local service that should the issue recur, a new complaint will be opened in order to conduct further investigation.

• Brand Name: VITEK MS MYCOB/NOCARDIA KIT
• Type of Device: VITEK MS MYCOB/NOCARDIA KIT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13118735
• MDR Text Key: 290167759
• Report Number: 9615754-2021-00303
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026436971
• UDI-Public: 03573026436971
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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 Model Number: VITEK® MS MYCOBACTERIUM/NOCARDIA KIT
• Device Catalogue Number: 415659
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1