MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 AST-GN69 TEST KIT

Catalog Number	413400
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of false susceptible results for an escherichia coli survey strain when testing with the vitek® 2 ast-gn69 test kit.The customer obtained a susceptible result (mic=8) for ampicillin/sulbactam.The expected result for this survey strain is intermediate or resistant.The customer retested the strain and obtained mic=16 (intermediate), which is acceptable for this survey.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states reported a false susceptible ampicillin/sulbactam result (mic=8) when they tested an escherichia coli api survey strain using vitek® 2ast-gn69 lot 5890743403.The expected result was resistant.Multiple requests for strain submittal from the customer have been unsuccessful.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.Vitek 2 ast-gn69 lot # 5890743403 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-GN69 TEST KIT
• Common Device Name: VITEK® 2 AST-GN69 TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7807114
• Report Number: 1950204-2018-00294
• Device Sequence Number: 1468940
• Product Code: LON
• UDI-Device Identifier: 03573026398460
• UDI-Public: 03573026398460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N50510: S 97
• 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): 11/02/2018

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: 12/09/2019
• Device Catalogue Number: 413400
• Device Lot Number: 5890743403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1