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 (b)(6) notified biomérieux of a false positive cefoxitin screen result for a staphylococcus aureus isolate in association with the vitek® 2 ast-gp75 test kit (ref.415670, lot 2751392103), as compared to kirby-bauer (kb).The customer stated the patient was flagged by the hospital as presumptive mrsa positive, was placed in isolation with other mrsa positive patients.Summary: vitek ast-gp75 (initial): cefoxitin screen positive, oxacillin tested susceptible (s) with therapeutic correction to resistant (r).Vitek ast-gp75 (repeat): no repeat results were provided by the customer.Alternate susceptibility test: kb cefoxitin disk - susceptible.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 canada regarding a false positive cefoxitin screen result for a staphylococcus aureus isolate in association with the vitek® 2 ast-gp75 test kit (ref.415670, lot 2751392103), as compared to kirby-bauer (kb).Local customer service (lcs) documented that the customer did repeat testing with the same lot, and obtained a negative cefoxitin screen result.The customer suspects that the original sample was contaminated, and said the issue was resolved.Global customer service (gcs) requested further information about the contamination that was suspected but did not receive any further information or any further answers to additional troubleshooting questions.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Ast-gp75 lot 2751392103 met final qc release criteria and passed qc performance testing.

• 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: 10616553
• Report Number: 1950204-2020-00196
• Device Sequence Number: 13741098
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/04/2020

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: 09/18/2021
• Device Catalogue Number: 415670
• Device Lot Number: 2751392103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1