MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP75 TEST KIT; AST-GP75 TEST KIT 20 CARDS - 415670

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
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
A customer in the united states notified biomérieux of a false positive cefoxitin screen result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp75 test kit (ref 415670).No lot numbers or lab reports were provided by the customer.The customer performed pbp2a testing as an alternative method and obtained negative results.Repeat analysis with the vitek® 2 ast-gp75 test kit obtained negative cefoxitin screen results.There is no indication or report from the laboratory that the initial false positive cefoxitin screen result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint for a false positive cefoxitin screen result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp75 test kit (ref 415670).No lot numbers or lab reports were provided by the customer.The customer was unwilling to submit the strain for investigation.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.The lot number for the implicated card type has not been provided by the customer, so complaint searches and qc performance review of the specific lot cannot be completed.The cause for the customer's false positive cefoxitin screen result cannot be established due to the strain not being submitted for investigation and insufficient information provided by the customer.

• Brand Name: VITEK® 2 AST-GP75 TEST KIT
• Common Device Name: AST-GP75 TEST KIT 20 CARDS - 415670
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9384350
• Report Number: 1950204-2019-00318
• Device Sequence Number: 2236897
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/11/2020

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 Catalogue Number: 415670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1