MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP67 TEST KIT; AST-GP67 TEST KIT 20 CARDS - 22226

Catalog Number	22226
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 (b)(6) notified biomérieux of false resistant oxacillin results for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 (ref 22226, lot 1321130103).Oxascreen and rapid (b)(6) testing were performed as alternative methods.Vitek® 2: oxacillin = resistant.Oxascreen: oxacillin = susceptible.Rapid mrsa: negative.There is no indication or report from the laboratory that the false resistant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint for false resistant oxacillin results for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref (b)(4), lot 1321130103).The customer¿s isolate was received and identified as staphylococcus lugdunensis via the vitek® 2 (99% confidence x2) and vitek® ms (99.9% confidence).It is unclear how the customer identified the isolate as staphylococcus aureus.Investigational testing of the isolate included vitek® 2 ast-gp67 test kit cards from the customer¿s lot (1321130103) and a random lot (1321316203), all in duplicate.In addition, oxacillin agar dilution and cefoxitin disk diffusion were also performed.For all cards tested, an oxacillin mic = 4 mg/l (resistant) was obtained, while aes modified the cefoxitin screen result from negative (susceptible) to positive (resistant).Oxacillin agar dilution yielded mic = 4 mg/l (resistant) and cefoxitin disc diffusion was susceptible (28 mm).Conclusion: the isolate was identified as staphylococcus lugdunensis instead of staphylococcus aureus.The customer¿s resistant oxacillin results were reproduced; however, testing of the isolate showed the vitek® 2 cards are in essential and categorical agreement with the reference method and are performing as intended.Ast-gp67 lot 1321130103 met final qc release criteria.The lot passed qc performance testing.See h10 for addtl mfg narrative.

• Brand Name: VITEK® 2 AST-GP67 TEST KIT
• Common Device Name: AST-GP67 TEST KIT 20 CARDS - 22226
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9538540
• Report Number: 1950204-2020-00001
• Device Sequence Number: 19448075
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N50510: S117
• 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): 03/26/2020

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: 12/30/2020
• Device Catalogue Number: 22226
• Device Lot Number: 1321130103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1