MAUDE Adverse Event Report: BIOMÉRIEUX, INC VITEK 2 AST-GP67 TEST KIT; VITEK® 2 AST-GP67 TEST KIT

Catalog Number	22226
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biom¿rieux of obtaining a false positive result for cefoxitin screen while testing a (b)(6) atcc¿ 29213" qc strain using the vitek¿ 2 ast-gp67 test kit (reference #: (b)(4), lot #: 1321529403).The customer stated they do not repeat vitek 2 results if they get a false positive cefoxitin screen.Instead they confirm results using pcr as an alternative testing method.A field service engineer (fse) went to the customer site on 15nov2020, and replaced the b side optics.The customer has had no issues since the optics were replaced.Since the customer is no longer having issues they have declined to provide further information at this time due to time-constraints.There is no patient associated with this qc isolate; therefore, there is no adverse event related to any patient's state of health.A biom¿rieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false positive result for cefoxitin screen while testing a staphylococcus aureus atcc® 29213¿ qc strain using the vitek® 2 ast-gp67 test kit (reference # 22226, lot # 1321529403).A field service engineer (fse) went to the customer site and replaced the b side optics.The customer has had no additional issues since the optics were replaced.Vitek® 2 ast-gp67 lot 1321529403 met final qc release criteria and passed qc performance testing.Since the customer had experienced no further issues after the fse visit, due to time constraints, they declined to provide further information (patient strain, lab reports, troubleshooting information).No further investigation is possible.

• Brand Name: VITEK 2 AST-GP67 TEST KIT
• Common Device Name: VITEK® 2 AST-GP67 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10932707
• Report Number: 1950204-2020-00208
• Device Sequence Number: 2758414
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/26/2021

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: 02/02/2022
• Device Catalogue Number: 22226
• Device Lot Number: 1321529403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1