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 resistant.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 us customer submitted their api escherichia coli survey strain ur-06 for ampicillin/sulbactam (ams) evaluation because susceptible results (mic=8) were obtained when the sample was tested on vitek® 2 ast-gn69 cards.The expected result for ams was resistant.Identification was confirmed, and testing included both the customer lot and a random lot of ast-gn69 cards.Agar dilution (ad), the reference method for ams (sam01n), was also performed.On the customer lot of ast-gn69 cards, a susceptible ams mic=8 was obtained, and, on the random lot, an intermediate mic=16 was obtained.Ad gave an intermediate mic=16.Both card results are within one (1) doubling dilution of reference method results, so card and reference method results are in agreement.The vitek 2 ast-gn69 cards performed as expected, and no further action is necessary.

• 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: 7827713
• Report Number: 1950204-2018-00312
• Device Sequence Number: 1175903
• Product Code: LON
• UDI-Device Identifier: 03573026398460
• UDI-Public: 03573026398460
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/08/2018

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: 10/04/2019
• Device Catalogue Number: 413400
• Device Lot Number: 5890677403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1