MAUDE Adverse Event Report: BIOMÉRIEUX, INC VITEK 2 AST-GP78 TEST KIT

Catalog Number 421051

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of obtaining a false positive cefoxitin screen result for a staphylococcus aureus isolate in association with the vitek® 2 ast-gp78 test kit (ref.421051, lot 2781427403) and software version 9.02.The customer stated the s.Aureus isolate obtained an oxacillin mic= 0.5 susceptible; this result was then modified to resistant based upon the positive cefoxitin screen result.Biomerieux customer service requested information regarding alternate susceptibility testing; this information has not yet been provided.Repeat testing was conducted and the expected negative result was obtained.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.Biomerieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states regarding false positive cefoxitin screen results for a staphylococcus aureus isolate in association with the vitek® 2 ast-gp78 test kit (ref.421051, lot 2781427403) and software version 9.02.The customer did not save the isolate; therefore, no investigational testing could be performed.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Vitek® 2 ast-gp78 lot 2781427403 met final qc release criteria, and passed qc performance testing.See section h10.

• Brand Name: VITEK 2 AST-GP78 TEST KIT
• Type of Device: VITEK 2 AST-GP78 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: tenika rhodes ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 11030475
• MDR Text Key: 247131298
• Report Number: 1950204-2020-00215
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 03573026553982
• UDI-Public: 03573026553982
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2021
• Device Catalogue Number: 421051
• Device Lot Number: 2781427403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1