MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 ANC TEST KIT

Catalog Number	21347
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
Additional Manufacturer Narrative
This report is being submitted as part of an fda request regarding supplemental reports that did not have an initial report on file.The initial report was originally submitted as 1950204-2016-00130 in error.A supplemental report for 1950204-2016-00130 has also been submitted to document the error and correction.
Event or Problem Description
A customer in (b)(6) contacted biomérieux to report a discrepant organism identification in association with the vitek® 2 anaerobic and corynebacteria (anc) identification (id) test kit.Propionibacterium species was misidentified as atopodium vaginae.Upon obtaining atopodium vaginae result for a male patient, an alternate method of testing (crystal) was employed.The result of propionibacterium agnes (or granuslosum) was obtained.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.Culture submittals have been requested by biomérieux for internal investigation.An internal biomérieux investigation will be initiated.

• Brand Name: VITEK® 2 ANC TEST KIT
• Common Device Name: VITEK® 2 ANC TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 5407895
• Report Number: 1950204-2016-00004
• Device Sequence Number: 11836366
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K910666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/24/2021

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 Expiration Date: 05/04/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244379420
• 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: 12/29/2015
• Supplement Date Received by Manufacturer: 12/29/2015
• Initial Report FDA Received Date: 02/03/2016
• Supplement Report FDA Received Date: 02/03/2016
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown