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
Event or Problem Description
A customer in (b)(6) notified biomerieux of a false positive cefoxitin screen for a patient staphylococcus aureus strain in association with the vitek® ast-gp67 test kit (ref# 22226, lot# 1321039203).Software version (b)(4).The customer identified the strain as staphylococcus aureus using the vitek® ms.Initial test results: ast-gp67.Lot 1321039203.Cefoxitin screen (oxsf) = positive.Oxacillin (ox1) - mic = 0.5, changed to resistant.Expected results: cefoxitin screen (oxsf) = negative.Oxacillin (ox1) = susceptible.Alternate test results: disk diffusion: cefoxitin = susceptible.Oxacillin = susceptible.Pcr filmarray pneumonia plus panel meca/c mecj not detected.Result: filmarray sa detected but not resistance genes.Repeat testing results: ast-gp67.Lot 1321039203.Cefoxitin screen (oxsf) = negative.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in hong kong regarding false positive cefoxitin screen (oxsf) results for a patient staphylococcus aureus strain in association with the vitek® ast-gp67 test kit (ref# 22226, lot# 1321039203).Software version 8.01.Initial testing resulted in a positive cefoxitin screen, while repeat testing was negative.The customer identified the strain as staphylococcus aureus using the vitek® ms.The isolate is not available for submittal.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference methods.Since the isolate could not be submitted for investigational purposes, no additional investigation could be completed.Vitek® 2 ast-gp67 cards, lot 1321039203 met final qc release criteria.This lot passed qc performance testing.

• 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: 9598354
• Report Number: 1950204-2020-00010
• Device Sequence Number: 2525650
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/12/2020

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: 09/30/2020
• Device Catalogue Number: 22226
• Device Lot Number: 1321039203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1