MAUDE Adverse Event Report: BIOMÉRIEUX, INC VITEK® 2 GN TEST KIT; GN TEST KIT VTK2 20CARDS

Catalog Number	21341
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
An internal complaint was initiated following a scientific publication entitled, "analysis on brucellosis epidemiological characteristics in hainan province" by wang xm, et al.The publication noted one (1)misidentification of brucella melitensis and four (4) misidentifications of brucella suis as ochrobactrum anthropi in association with the vitek® 2 gn id test kit, using software version (b)(4).The publication does not reference the lot number(s) of vitek 2 gn id test kit used.Traditional biotyping methods identified eleven (11) strains as brucella melitensis biovar 3, and five (5) strains as brucella suis biovar 3.There is no indication from the publication 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
An investigation was initiated in response to an internal complaint following a scientific publication entitled, "analysis on brucellosis epidemiological characteristics in hainan province" by wang xm, et al.The publication noted one (1) misidentification of brucella melitensis and four (4) misidentifications of brucella suis as ochrobactrum anthropi in association with the vitek® 2 gn id test kit, using software version 7.01.The publication does not reference the lot number(s) of vitek 2 gn id test kit used.Isolates, lab reports, and troubleshooting details were not able to be obtained from the authors of the publication.Without strain submittal the reported misidentification cannot be confirmed and a potential cause for the claimed misidentification cannot be established.Vitek® 2 software version 9.02 addresses the issue of misidentification of brucella species as ochrobactrum anthropi by adding a note that states, "possibility of brucella species." the lot numbers of the implicated gn cards are not available, so complaint searches and qc performance review of the lots cannot be performed.Global customer service (gcs) queried trackwise (tw) for misidentification of brucella species from 12aug2018 to 13sep2019, returning only one complaint and associated with this investigation.No capas or ncmrs were opened for this performance issue during the same time frame.Gcs review of the most recent quarterly trend report, q1 2019, did not identify this complaint as a systemic quality issue.
Additional Manufacturer Narrative
In alignment with the most recent fda guidance, "medical device reporting for manufacturers, issued november 8, 2016", biomérieux is submitting this notification to fda to inform the agency of the decision to cease reporting specific vitek® 2 malfunction events after two years of no occurrences associated with death or serious injury.For the specific combinations of product and malfunction type, customer complaints were reviewed over a two year period starting from the date of awareness of the most recent event that was classified as a serious injury or death.For the following malfunction types, this review identified no additional occurrences of being associated with death or serious injury for two years.Product code: lqm.Reference: (b)(4).Malfunction: misidentification of brucella suis.Final mdr submitted: 1950204-2019-00239 we wish to inform you that with the completion of our mdr data analysis, we have updated our mdr criteria for vitek 2 product code lqm, and will no longer report these malfunction events because they have not caused or contributed to a death or serious injury in the past two years.Moving forward, if biomérieux becomes aware of a death or serious injury event for the malfunctions referenced above, we will report that event to the fda per the fda mdr guidance, and will update our mdr criteria to require reporting the specific associated malfunction as required by this guidance.

• Brand Name: VITEK® 2 GN TEST KIT
• Common Device Name: GN TEST KIT VTK2 20CARDS
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 8838773
• Report Number: 1950204-2019-00239
• Device Sequence Number: 2586818
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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 Catalogue Number: 21341
• 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: 07/03/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 01/06/2022
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 10/10/2019; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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