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

Catalog Number	22226
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal biomérieux investigation was completed.The customer no longer had the strain, so it could not be submitted for investigational testing.Submittal of the isolates is required in order to confirm a vitek® 2 discrepancy compared to the reference methods.Since the strains could not be submitted for investigational purposes, no additional investigation could be completed.Ast-gp67 lot 1321130103 met final qc release criteria.This lot passed qc performance testing.
Event or Problem Description
A customer in the united states notified biomérieux of obtaining a false positive cefoxitin screen when testing a staphylococcus aureus patient isolate with the vitek® 2 ast-gp67 test kit (reference # 22226, lot # 1321130103).The customer was trying to validate the ast-gp75 card and received conflicting results.Ast-gp67 card: oxacillin mic = 2 susceptible, cefoxitin screen = positive, set up from original culture.Ast-gp75 card: oxacillin mic <= 0.25, cefoxitin screen = negative, set up from purity plate.Repeat testing of the ast-gp67 card: oxacillin mic = 2 susceptible, cefoxitin screen = negative.There is no indication or report from the hospital that the discrepant result led to any adverse event related to the patient's state of health.

• Brand Name: VITEK® 2 AST-GP67 TEST KIT
• Common Device Name: VITEK® 2 AST-GP67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9328146
• Report Number: 1950204-2019-00314
• Device Sequence Number: 1951028
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 11/15/2019

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 Expiration Date: 12/30/2020
• Device Catalogue Number: 22226
• Device Lot Number: 1321130103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1