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

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 obtaining a (b)(6) resistant oxacillin result for (b)(6) while testing a patient urine sample using the vitek® 2 ast-gp67 test kit (reference # 22226, lot # 1321295403).Initial vitek® 2: oxacillin mic >= 4, (resistant).Repeat vitek® 2: oxacillin mic >= 4, (resistant).Alternate method results: (b)(6) rapide and oxascreen: (b)(6) (susceptible) identification confirmed as (b)(6).The oxacillin susceptible results from the manual methods were reported to the physician; therefore, no wrong results were reported.The customer stated that there was a delay of >24 hours in reporting the result, but 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
This report was initially submitted following notification from a customer in canada regarding a false resistant oxacillin result for staphylococcus aureus while testing a patient urine sample using the vitek® 2 ast-gp67 test kit (reference # (b)(4), lot # 1321295403).Initial vitek® 2: oxacillin mic >= 4, (resistant).Repeat vitek® 2: oxacillin mic >= 4, (resistant).Alternate method results: mrsa rapide and oxascreen: negative (susceptible).The customer provided information that pbp2a test results were also negative.A biomérieux internal investigation has been completed with the following results: the isolate was tested in duplicate using the customer lot and a random lot (1321245403) of ast-gp67 cards.On all cards a susceptible oxacillin result was obtained (mic= 0.5).All four cards resulted in negative cefoxitin screen results.The isolate was also tested using ox agar dilution, the reference method for ox101n, with susceptible oxacillin results (mic = 0.5).Cefoxitin (fox) disc testing was performed, the reference method for the oxsf01n test found on the ast-gp67 card, with negative results (23 mm).Pbp2a testing results were also negative.Therefore, the vitek® 2 ast-gp67 cards and reference method results are in agreement; the cards are performing as intended.Vitek® 2 ast-gp67 cards, lot 1321295403, met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK 2 AST-GP67 TEST KIT
• Common Device Name: VITEK® 2 AST-GP67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10441616
• Report Number: 1950204-2020-00150
• Device Sequence Number: 11755810
• 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): 10/21/2020

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: 06/13/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321295403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1