MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK 2 COMPACT 30 - 27530

Model Number	27530
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the vitek® 2 system is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and yeast.The vitek® 2 system is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non-fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Description of the issue: a customer in spain notified biomerieux of obtaining false resistant results when using the vitek 2 compact 30 - reference (b)(4) ( serial number (b)(4)).At the moment, it has not been notified which strains or antimicrobials are concerned by the false resistant results.The customer indicates that alternate method and repeat testing have been performed to confirm the expected susceptible results.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.This discrepancy was reviewed for vigilance reporting according to 21 cfr 803 concerning medical device reporting.Biomerieux internal standard operational procedures states that erroneous test results could result in a lack of appropriate diagnosis or therapy, continued administration of inappropriate antimicrobials, or other potentially toxic therapies.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomerieux internal investigation will be initiated.
Additional Manufacturer Narrative
Context: a customer in spain notified biomerieux of obtaining false resistant results when using the vitek 2 compact 30 - reference (b)(4) (serial number #(b)(6)).Investigation results: multiple attempts for additional information have been unsuccessful.Therefore, there has been no clarification of product, strains or antimicrobials impacted for this complaint.Conclusion: submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.Without strain submittal, laboratory reports, product type, card lot, implicated organisms or implicated drug information, it is not possible to further evaluate the cause of this customer's complaint.

• Brand Name: VITEK 2 COMPACT 30 - 27530
• Common Device Name: VITEK 2 COMPACT 30 - 27530
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: pauline previtali ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15892743
• Report Number: 1950204-2022-00048
• Device Sequence Number: 6699434
• Product Code: LON
• UDI-Device Identifier: 03573026136789
• UDI-Public: 03573026136789
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050002
• 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): 12/16/2022

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: 27530
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/16/2022
• 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