MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK 2 AST-GP75 TEST KIT; VITEK® 2 AST-GP75 TEST KIT

Catalog Number	415670
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomerieux of obtaining a false positive cefoxitin screen result for staphylococcus aureus atcc® 259213¿ in association with the vitek® 2 ast-gp75 test kit (ref.415670, lot 2751557403).The s.Aureus atcc® 259213¿ isolate was cultured on sheep blood agar and incubated without carbon dioxide at 35°c for 24 hours prior to testing.The vitek 2 testing was then performed with lot 2751557403 and obtained a positive cefoxitin screen result.The customer confirmed the expected cefoxitin screen result s.Aureus atcc® 259213¿ is negative.The customer cleaned the instrument optics then performed repeat testing using a fresh cultiloop cultured on sheep blood agar incubated at 35°c with carbon dioxide for 24 hours.The expected negative cefoxitin screen result was obtained.It should be noted that staphylococcus aureus can be incubated with or without carbon dioxide on sheep blood agar according to the package insert culture requirements table.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomerieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false positive cefoxitin screen (oxsf) result for staphylococcus aureus atcc® 259213¿ in association with the vitek® 2 ast-gp75 test kit ((b)(4), lot 2751557403).No lab reports, troubleshooting information, or the strain was available for investigation evaluation.Internal testing was conducted using cards from the customer's lot and a random lot of ast-gp75 cards, 2751494403, in duplicate.Testing was conducted using the internal biomérieux staphylococcus aureus atcc strain 29213 (694).Testing on all of the cards resulted in the expected negative oxsf results.The customer's false positive oxsf result was not reproduced when testing from the biomerieux internal qc strain.Vitek 2 ast-gp75 lot 2751557403 met final qc release criteria.In addition, the customer had their reader optics replaced by a field service engineer (fse), and has experienced no further issues.

• Brand Name: VITEK 2 AST-GP75 TEST KIT
• Common Device Name: VITEK® 2 AST-GP75 TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11059394
• Report Number: 1950204-2020-00218
• Device Sequence Number: 16862950
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• 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): 01/25/2021

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: 03/02/2022
• Device Catalogue Number: 415670
• Device Lot Number: 2751557403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1