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

Catalog Number	415670
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a false negative cefoxitin screen (oxsf) result for a patient staphylococcus aureus wound isolate while using the vitek® 2 ast-gp75 test kit (reference 415670, lot 2751099203).The isolate was repeated on the vitek 2 using the same lot of cards and tested using genexpert® pcr.The vitek 2 obtained a negative cefoxitin screen result however; the genexpert pcr result was oxsf positive.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false negative cefoxitin screen (oxsf) result for a patient staphylococcus aureus wound isolate while using the vitek® 2 ast-gp75 test kit (reference 415670, lot 2751099203).The isolate was repeated on the vitek 2 using the same lot of cards and tested using genexpert® pcr.The vitek 2 obtained a negative cefoxitin screen result while the genexpert pcr result was oxsf positive.Biomérieux investigation was conducted.However, the patient strain was no longer available for submittal and investigation.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.Local customer service (lcs) confirmed the customer cleans the dispensettes with soap and water, and the tips cleaned with alcohol in addition to autoclaving monthly.The customer was been advised that autoclaving is the only recommend method for cleaning the dispensette as alcohol and detergent can potentially cause organism growth issues inside of the card, leading to inaccurate results.Vitek 2 ast-gp75 lot # 2751099203 met final qc release criteria.This lot passed qc performance testing.No ncmrs were written against this lot.Ncmrs were reviewed for the last 13 months (30sep2018 to 30oct2019).No ncmrs were written for the ast-gp75 card for performance issues.Without submittal of the isolate, no further investigation is possible.

• Brand Name: VITEK® 2 AST-GP75 TEST KIT
• Common Device Name: VITEK® 2 AST-GP75 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9072385
• Report Number: 1950204-2019-00268
• Device Sequence Number: 16581739
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/21/2019

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: 11/29/2020
• Device Catalogue Number: 415670
• Device Lot Number: 2751099203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1