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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the (b)(6) notified biom¿rieux of obtaining false positive (resistant) cefoxitin screen results for staphylococcus aureus for six (6) different patients in association with the vitek¿ 2 ast-gp75 test kit ref 415670, lot 2751438113.The customer stated that cefoxitin screen results were positive while the oxacillin results were susceptible (mic<=0.25 or =0.5), but aes (advanced expert system") corrected the interpretation for oxacillin to resistant based on the positive cefoxitin screen results.The customer does not perform any alternative method for cefoxitin screen, but disk diffusion testing for oxacillin was performed and obtained susceptible results.A field service engineer (fse) visited the customer's site and cleaned the instrument's optics and checked the alignment.The customer reported that they have not obtained any discrepant cefoxitin screen results since the optics cleaning and alignment.Retest of three (3) of the original six (6) isolates obtained the expected results.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.A biomerieux investigation has been initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding false positive (resistant) cefoxitin screen results for staphylococcus aureus for six (6) different patients in association with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2751438113).A field service engineer (fse) visited the customer's site ((b)(6) 2020) and cleaned the instrument's optics and checked the alignment.The customer reported that they have not obtained any discrepant cefoxitin screen results since the optics cleaning and alignment.Product return was not received; the customer¿s strains were not saved for submittal and investigation.The customer only provided lab reports associated with one (1) isolate.They did not provide any other lab reports.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Vitek® 2 ast-gp75 lot 2751438113 met final qc release criteria, and passed qc performance testing.See section h10.

• 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: 11123925
• Report Number: 1950204-2021-00006
• Device Sequence Number: 16326092
• 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): 02/03/2021

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: 11/03/2021
• Device Catalogue Number: 415670
• Device Lot Number: 2751438113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1