MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-P612 TEST KIT

Catalog Number	22359
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of false (b)(6) cefoxitin screen results when testing staphylococcus aureus with the vitek® 2 ast-p612 test kit (ref.(b)(4)), software v8.01.The customer reported obtaining the following results for multiple isolates on initial testing: oxacillin mic <=0.25 or 0.5mg/l, cefoxitin screen (b)(6) (resistant), cefoxitin disc >=22mm (susceptible).Initially, the customer tested 10 of these isolates further using xpert® mrsa nxg - all resulted as non-mrsa isolates.(note, xpert mrsa nxg - detects both meca and mecc).Subsequently, the customer repeated the ast for nine (9) isolates, and on repeat testing the result was cefoxitin screen (b)(6).The customer reported that there was no patient harmed or treated incorrectly due to the discrepant result.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was completed in response to a customer complaint of false positive cefoxitin screen (oxsf) results when testing staphylococcus aureus isolates with the vitek® 2 ast-p612 test kit (ref.22359, lot 4920900103).The customer submitted one (1) strain for investigational testing.The submitted strain was verified to be staphylococcus aureus with the vitek® ms.A second subculture was performed and testing included ast-p612 cards from the customer lot (4920900103) and a random lot (4921040203) in duplicate, as well as oxacillin (ox) agar dilution (ad) and cefoxitin disk diffusion as the reference methods for ox101n and oxsf01n formulations found on this card, and alere pbp2.----reference methods---- oxacillin agar dilution mic = 0.5 (susceptible) cefoxitin disk diffusion: 22 mm (susceptible) pbp2a = neg ----vitek® 2 ast-p612---- all results for the ast-p612 cards from the customer lot and the random lot were negative oxsf tests and oxacillin mics = 0.5 (susceptible).The customer's false positive result was not reproduced internally.The vitek® 2 cards are in essential agreement with the reference methods tested.Ast-p612 lot # 4920900103 met final qc release criteria.The lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-P612 TEST KIT
• Common Device Name: VITEK® 2 AST-P612 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8727871
• Report Number: 1950204-2019-00199
• Device Sequence Number: 2231823
• Product Code: LON
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/16/2019

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: 05/14/2020
• Device Catalogue Number: 22359
• Device Lot Number: 4920900103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1