MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK 2 AST-GP67 TEST KIT; VITEK® 2 AST-GP67 TEST KIT

Catalog Number	22226
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomerieux of a false positive (resistant) cefoxitin screen result for a staphylococcus aureus qc strain in association with vitek® 2 ast-gp67 test kit (ref.22226, lot 1321335203).The initial test provided a result of cefoxitin screen positive.The expected result was negative.A repeat test was performed, and the result was negative.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomerieux internal investigation will be initiated.
Additional Manufacturer Narrative
Biomérieux conducted an internal investigation in response to a customer compliant of a false positive (resistant) cefoxitin screen result for staphylococcus aureus in association with vitek® 2 ast-gp67 test kit (ref.22226, lot 1321335203).Initial testing conducted on 08jun2020 yielded a positive oxfs result while repeat testing on 09 and 10jun2020 was oxsf negative for both lots.The customer stated initial testing was performed after culture was incubated for twelve (12) hours.This is outside the eighteen to twenty-four (18-24) hour range published in product labeling (ifu).Vitek® 2 ast-gp67 lot 1321166403 and 1321335203 met final qc release criteria.The lots passed qc performance testing.The root cause was determined to be user error.The device is performing as intended.

• Brand Name: VITEK 2 AST-GP67 TEST KIT
• Common Device Name: VITEK® 2 AST-GP67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10196576
• Report Number: 1950204-2020-00134
• Device Sequence Number: 3297592
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• 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): 09/16/2020

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: 07/23/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321335203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1