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

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 the united states notified biomérieux of a false resistant oxacillin result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321158103).Initial testing completed with 1321079103 obtained resistant oxacillin results.Alternate testing results showed that the isolate was pbp2a negative and meca negative.Disk diffusion testing obtained (b)(6) results.The strain was sent to a reference laboratory and confirmed to be (b)(6).Vitek® 2 ast-gp67 test kit (ref 22226, lot 1321158103) was used for repeat analysis after receiving results from the reference laboratory and obtained resistant oxacillin results.The customer reported that the patient was treated with vancomycin due to the initial resistant ox result.There is no indication or report from the laboratory that the discrepant result and treatment with vancomycin led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false resistant oxacillin result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321158103).The strain was submitted for investigational testing and the identification was confirmed to be staphylococcus aureus via vitek® 2 using vitek gp id card (lot 2420931203).Investigational testing included testing the strain using reference methods as well as analyzing the strain in duplicate using the customer lots (1321079103 and 1321158103) and a random lot (1321091203).---reference test results--- agar dilution (ad) oxacillin: mic = 4.0 (r) cefoxitin disk diffusion: 25mm (s).Pbp2a = negative ---- vitek® 2 results---- all 6 cards tested resulted in a resistant ox mic >= 4.0 and a negative oxfs result that was corrected to positive by the aes software.----conclusions---- to summarize, customer's results were duplicated, however, testing is in both essential and categorical agreement with reference method testing.Isolate is a borderline resistant strain.Cards are performing as intended.Ast-gp67, lot 1321079103 and 1321158103 met final qc release criteria.These lots passed qc performance testing.

• Brand Name: VITEK® 2 AST-GP67 TEST KIT
• Common Device Name: AST-GP67 TEST KIT 20 CARDS
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9257140
• Report Number: 1950204-2019-00300
• Device Sequence Number: 14385503
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N50510: S117
• 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): 11/15/2019

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: 01/27/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321158103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1