MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP67 TEST KIT; AST-GP67 TEST KIT 20 CARDS

Catalog Number	22226
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of obtaining a false positive cefoxitin screen (oxfs) result for staphylococcus aureus (s.Aureus) atcc® 29219¿ while using the vitek® 2 ast-gp67 test kit (ref.22226, lot 1321079103) with software version 8.01.The customer repeated testing on the vitek 2 which yielded a positive oxfs result.The customer stated the expected result for s.Aureus atcc 29219 was oxfs negative.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false positive cefoxitin screen (oxfs) result for staphylococcus aureus (s.Aureus) atcc® 29213¿ while using the vitek® 2 ast-gp67 test kit (ref.22226, lot 1321079103) with software version 8.01.The customer repeated testing on the vitek® 2 which yielded a positive oxfs result.The customer stated the expected result for s.Aureus atcc® 29213¿ was oxfs negative.The identification of the customer's submitted strain and biomerieux internal strain of s.Aureus atcc® 29213¿ was confirmed.Investigation testing was performed on both strains using ast-gp67 cards from the customer lot (1321079103) and a random lot (1321123103) in duplicate.All ast-gp67 cards tested resulted in the expected negative oxsf test.No qc deviations were observed.Vitek® 2 ast-gp67 cards, lots 1321079103, met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-GP67 TEST KIT
• Common Device Name: AST-GP67 TEST KIT 20 CARDS
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9207789
• Report Number: 1950204-2019-00307
• Device Sequence Number: 16908571
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/16/2019

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: 11/09/2020
• Device Catalogue Number: 22226
• Device Lot Number: 1321079103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1