MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-GN70 TEST KIT

Catalog Number	413401
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 from the united states notified biomérieux of false resistant trimethoprim/sulfamethoxazole results when testing with the vitek ® 2 ast-gn70 test kit (ref 413401, lot 5900663403).A patient's tracheal aspirate sample was identified as stenotrophomonas maltophilia.Susceptibility testing on the ast-gn70 obtained a resistant result (mic = 80) on initial testing with lot 5900663403 and repeat testing on lot 5900755403.The physician questioned the resistant result; therefore, the strain was sent to another lab for testing.The external lab used microscan and obtained a susceptible result (mic <= 2/38).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.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for false resistant trimethoprim/sulfamethoxazole (sxt) results (mic= 80) when testing a s.Maltophilia isolate on vitek® 2 ast-gn70, lot # 5900663403 and 5900755403.A reference lab obtained susceptible results (mic=40).Vitek 2 mics that are within one doubling dilution of reference method mics are considered acceptable results for the vitek 2.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference.It should be noted that the fda drug label for sxt does not include indications for s.Maltophilia.The vitek 2 ast-gn70 lot # 5900663403 and 5900755403 met final qc release criteria, and passed qc performance testing.A complaint search against ast-gn70 card lots 5900663403 and 5900755403 did not indicate any issues for these lots.

• Brand Name: VITEK® 2 AST-GN70 TEST KIT
• Common Device Name: VITEK® 2 AST-GN70 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7915660
• Report Number: 1950204-2018-00397
• Device Sequence Number: 10955216
• Product Code: LON
• UDI-Device Identifier: 03573026398477
• UDI-Public: 03573026398477
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K110106
• 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): 12/11/2018

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: 09/20/2019
• Device Catalogue Number: 413401
• Device Lot Number: 5900663403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1