MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 AST-GP78 TEST KIT; VITEK® 2 AST-GP78 TEST KIT

Catalog Number	421051
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 obtaining a false resistant oxacillin result in association with the vitek® 2 ast-gp78 test kit (ref.421051, lot 2781427403) when testing a patient staphylococcus aureus isolate.The customer stated lot 2781427403 obtained an oxacillin mic >=4 resistant.This resistant result then caused the negative cefoxitin screen result to be modified to positive by the vitek® 2 advanced expert system¿ (aes).The isolate was repeated using the same card lot and with the vitek® 2 ast-gp67 test kit (ref.22226 lot, 1321480203).Both card lots obtained an oxacillin mic >=4 resistant.Refer to cn-091084 for false resistant result associated with lot 1321480203.The customer also tested the staphylococcus aureus isolate using the oxplate, pcr, and pbp2a test methods.All alternative test methods obtained a negative result.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux has initiated an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false resistant oxacillin result in association with the vitek® 2 ast-gp78 test kit (ref.(b)(4), lot 2781427403) when testing a patient staphylococcus aureus isolate.Lot 2781427403 obtained an oxacillin mic>=4 resistant.This resistant result then caused the negative cefoxitin screen result to be modified to positive by the vitek® 2 advanced expert system¿ (aes).An internal biomerieux investigation was performed including testing of the customer's submitted strain.Identification of the organism was confirmed.The investigation included testing the strain with the customer¿s lot (ast- gp78), along with a random lot (2781514203) in duplicate.Agar dilution (ad), the reference method for ox (ox101n) was performed, as was broth microdilution (bmd).Cefoxitin (fox) disc testing was performed, which is the reference method for the oxsf (oxsf01n) test, as was pbp2a latex testing.On all ast- gp78 cards tested, a resistant ox mic>=4 was obtained.Ox ad gave a susceptible mic= 1 and bmd gave a susceptible mic=0.5.The customer's false resistant result was reproduced.On all cards tested, a negative oxsf result was obtained, which was forced positive due to the resistant ox results.Fox disc diffusion results were susceptible (24 mm) and pbp2a testing was negative.The uncorrected negative oxsf results are in agreement with the reference method results.This is an atypical strain and will be added to the biomerieux's internal r&d stock collection.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.The vitek 2 ast-gp67 lot 1321480203 met final qc release criteria and passed qc performance testing.

• Brand Name: VITEK 2 AST-GP78 TEST KIT
• Common Device Name: VITEK® 2 AST-GP78 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10572888
• Report Number: 1950204-2020-00184
• Device Sequence Number: 1270457
• Product Code: LON
• UDI-Device Identifier: 03573026553982
• UDI-Public: 03573026553982
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/24/2020

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: 10/23/2021
• Device Catalogue Number: 421051
• Device Lot Number: 2781427403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1