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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a false positive cefoxitin screen for staphylococcus aureus when performing antibiotic susceptibility testing on qc strain atcc 29213 when using the vitek® 2 ast-gp75 test kit (reference 415670), lot 2750951203.The customer obtained the following results for the qc strain: expected organism: atcc 29213, staphylococcus aureus.Initial vitek 2 ast-gp75 card: on (b)(6) 2019: cefoxitin screen, positive.Repeat vitek 2 ast-gp75 card: on (b)(6) 2019: cefoxitin screen, positive.On (b)(6) 2019: cefoxitin screen, positive.On (b)(6) 2019: cefoxitin screen, negative.On (b)(6) 2019: cefoxitin screen, negative.The customer reported that the densichek was calibrated, and that trypticase soy agar with blood was used to prepare subcultures, at an 18-24 hour incubation at 35-36°c, under non-co2 conditions.As the customer's strain was a quality control strain, no patient results were reported.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a false positive cefoxitin screen for staphylococcus aureus qc strain atcc 29213 with the vitek® 2 ast-gp75 test kit (reference 415670), lot 2750951203.The qc strain used by the customer was not available for testing; an internal biomerieux strain was tested.The internal s.Aureus atcc 29213 strain was subbed and tested on the customer lot 2750951203 and a random lot (2750712403), in duplicate, using vvitek 2 8.01 software.For all cards tested, the expected negative oxsf result was obtained.No other qc deviations were observed.Cards are performing as expected for the internal qc strain.A review of the most recent quarterly trend review (q3 2018), and the complaint search against ast-gp75 card lot 2750951203 did not indicate a trend of any issues for this lot.

• 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: 8529681
• Report Number: 1950204-2019-00102
• Device Sequence Number: 2798364
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/31/2019

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: No Information
• Device Expiration Date: 07/04/2020
• Device Catalogue Number: 415670
• Device Lot Number: 2750951203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1