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

Catalog Number	21347
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of misidentification results in association with vitek® 2 anc test kit (ref 21347).The customer reported that three patient strains were tested with vitek® 2, which provided identifications of fusobacterium nucleatum.Vitek® ms was used to test the isolates, and it provided either a "no id" result or campylobacter jejuni result.The state lab identified the strains as campylobacter concisus using the bruker method.Fusobacterium nucleatum was incorrectly reported to the physician for one of the patients.There is no information on reported results for the other two patients.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer reported misidentification results in association with vitek® 2 anc test kit (ref 21347) for three patient strains.An investigation was performed.The customer did not provide the stains, lab reports or raw data for evaluation.The customer reported that the anc card identified the strains as fusobacterium nucleatum or unidentified.The anc card requires a gram stain to be performed.Gram and morphology are required offline tests in order to complete the identification analysis.F.Nucleatum gram stains as long slender gram negative rods with pointed ends.C.Concisus gram stains as curved or corkscrew gram negative rods.Based on the gram stain results an identification of f.Nucleatum should be questioned.C.Concisus is an unclaimed species for the vitek 2 anc card database when an isolate is tested in the anc card, it will attempt to match the reactions to known reaction patterns stored in the knowledge base.If the reaction pattern of an unclaimed species is tested, and match those in the knowledge base with a high degree of confidence, a misidentification can occur.The vitek 2 product labeling contains the following warning in the limitations section: testing of unclaimed species may result in an unidentified result or a misidentification.

• Brand Name: VITEK® 2 ANC TEST KIT
• Common Device Name: VITEK® 2 ANC TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7052832
• Report Number: 1950204-2017-00417
• Device Sequence Number: 13780697
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K910666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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 Catalogue Number: 21347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1