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

Catalog Number	421051
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 from the united states notified biom¿rieux 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 (b)(4).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.
Additional 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.(b)(4), 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
• Common Device Name: VITEK 2 AST-GP78 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11030422
• Report Number: 1950204-2020-00216
• Device Sequence Number: 3486804
• Product Code: LON
• UDI-Device Identifier: 03573026553982
• UDI-Public: 03573026553982
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2021
• Device Catalogue Number: 421051
• Device Lot Number: 2781427403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1