MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP67 TEST KIT; AST-GP67 TEST KIT 20 CARDS - 22226

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 false positive cefoxitin screen results for a staphylococcus aureus atcc® 29213¿ isolate in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321211203).The strain was tested by (b)(6) with another lot of the vitek® 2 ast-gp67 test kit and obtained the expected negative cefoxitin screen result.As this was a qc strain, there was no patient involved.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An investigation was completed in response to a customer complaint for false positive cefoxitin screen results for a staphylococcus aureus atcc® 29213¿ strain in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321211203).The investigation also included lot 1321079103, related to another complaint from the same customer.Investigational testing included both the customer's staphylococcus aureus atcc® 29213¿ strain as well as an internal biomérieux staphylococcus aureus atcc® 29213¿ strain.Both strains were tested on the customer's lots (1321211203, 1321079103) and a random lot (1321123103) in duplicate.All six (6) ast-gp67 cards tested obtained the expected negative cefoxitin screen results.A review of complaints related to the lots used in the investigation did not indicate a trend for these lots.Ast-gp67 lots 1321079103, 1320596203 and 1321211203 met final qc release criteria.These lots passed qc performance testing.The customer's false positive cefoxitin screen results were not reproduced internally and the vitek® 2 ast-gp67 test kit cards are performing as expected.See h10 for additional mfg narrative.

• Brand Name: VITEK® 2 AST-GP67 TEST KIT
• Common Device Name: AST-GP67 TEST KIT 20 CARDS - 22226
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9416225
• Report Number: 1950204-2019-00323
• Device Sequence Number: 11190441
• 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): 01/02/2020

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: 03/21/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321211203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1