MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 COMPACT 60; VITEK 2 COMPACT 60

Model Number	27560
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
A customer in the (b)(6) notified biomérieux of false positive cefoxitin screen results for (b)(6) when performing antimicrobial susceptibility testing (ast) with the vitek® 2 compact 60 after a software version upgrade to 8.01.The specific ast card type and lot information were not provided by the customer.The customer is using the disk diffusion method to verify the susceptibility results for (b)(6) isolates.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification by a customer in the united kingdom regarding false positive cefoxitin screen results for staphylococcus aureus when performing antimicrobial susceptibility testing (ast) with the vitek® 2 compact 60 after a software version upgrade to 8.01.The specific ast card type and lot information were not provided by the customer.Biomérieux internal investigation was conducted; however, the customer did not comply with biomérieux's request for lab reports, raw data or isolate submittal.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.No further investigation is possible.

• Brand Name: VITEK® 2 COMPACT 60
• Common Device Name: VITEK 2 COMPACT 60
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9126156
• Report Number: 1950204-2019-00292
• Device Sequence Number: 2333286
• Product Code: LON
• UDI-Device Identifier: 03573026136796
• UDI-Public: 03573026136796
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K053097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 27560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1