MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 AST-GP67 TEST KIT; VITEK® 2 AST-GP67 TEST KIT

Catalog Number	22226
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 united states notified biomérieux of obtaining false (b)(6) cefoxitin screen results for a patient (b)(6) isolate in association with the vitek® 2 ast-gp67 test kit (ref (b)(4), lot 1321384203).The (b)(6) cefoxitin screen results are obtained on one instrument, but the customer's other instrument obtains (b)(6) results.Kirby bauer disk diffusion testing was performed as an alternative method and obtained (b)(6) (susceptible) results.Repeat analysis with the vitek® 2 ast-gp67 test kit was performed on two different instruments.The instrument used for initial testing obtained the same (b)(6) result when repeat analysis was performed.The other instrument obtained the expected (b)(6) (susceptible) result.There is no indication or report from the customer that the (b)(6) cefoxitin screen results led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
Biomérieux conducted an internal investigation in response to a customer complaint of a false positive cefoxitin screen when testing a patient staphylococcus aureus isolate using the vitek® 2 ast-gp67 test kit lot 1321384203.A biomérieux field service engineer (fse) visited the customer site and replaced the reader optics of the vitek® 2.Repeat testing of the patient staphylococcus aureus isolate was performed after the optics were replaced and a cefoxitin screen negative result was obtained.The customer data was requested but not submitted to biomérieux for investigation.Biomérieux reviewed the production and final qc release data associated with lot 1321384203.The review determined lot 1321384203 had no anomalies during the manufacturing process and lot met final qc release criteria.The cause of the customer¿s false positive cefoxitin screen result was not established.However, there is no evidence which suggests that lot 1321384203 is not functioning as intended.

• Brand Name: VITEK 2 AST-GP67 TEST KIT
• Common Device Name: VITEK® 2 AST-GP67 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10339584
• Report Number: 1950204-2020-00143
• Device Sequence Number: 19561191
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K053097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 09/10/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321384203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1