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

Model Number	VITEK® MS MYCOBACTERIUM/NOCARDIA KIT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9615754-2021-00303
• Device Sequence Number: 4485803
• Product Code: QBN
• UDI-Device Identifier: 03573026436971
• UDI-Public: 03573026436971
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K181412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown