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

Catalog Number	415670
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
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 (b)(6) cefoxitin screen result of a staphylococcus aureus isolate while using the vitek® 2 ast-gp75 test kit (ref # (b)(4), lot# 2750996203) with software version 9.01.The patient isolate was repeated using the same lot of ast-gp75 cards and was also tested using cephidae genexpert® pcr.The results are listed below: isolate results: vitek 2 original cefoxitin screen result - (b)(6) (susceptible).Vitek 2 repeat cefoxitin screen result - (b)(6) (susceptible).Cephidae genexpert pcr result - (b)(6) (resistant).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.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a false negative cefoxitin screen (oxsf) result for a staphylococcus aureus isolate on vitek® 2 ast-gp75 card, lot 2750996203.The customer was using v9.01 software with an enabled a bioart rule as described in the us fsca 4018.Genexpert pcr results were (b)(6) for (b)(6).The organism was subbed to tsab, and identification was confirmed with vitek ms.Testing was performed in duplicate on both the customer lot and a random lot (2750951203) of ast-gp75 cards.Oxacillin (ox) agar dilution testing (ad), which is the reference method for ox101n, was performed, as was cefoxitin disc diffusion testing, the reference method for cefoxitin screen (oxsf01n).Alere pbp2a testing was also performed.On all four cards, susceptible ox mics=0.5 or 1 were obtained.Ox ad gave a susceptible mic=1, so card and reference method results for ox are in essential and categorical agreement.On all four cards, negative oxsf results were obtained.Cefoxitin disc diffusion was susceptible (27 mm); however, pbp2a testing was positive, indicating this strain to be a cryptic mrsa with low-level expression of methicillin resistance.This is an atypical strain expressing low-level methicillin resistance.

• 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: 8631484
• Report Number: 1950204-2019-00142
• Device Sequence Number: 1643761
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• 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): 07/08/2019

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: 08/18/2020
• Device Catalogue Number: 415670
• Device Lot Number: 2750996203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1