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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of discrepant results associated with vitek® 2 ast-gn70 test kit (reference 413401).The customer reported receiving an incorrect result on the api survey.On an escherichia coli isolate, ampicillin/sulbactam and cefepime were reported as sensitive.The expected results for these drugs were intermediate or resistant.There was no patient involved in this event.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
510k number updated to n50510: s97.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to false results associated with the vitek® 2 ast-gn70 card when testing api survey strain ur-06 escherichia coli.Ampicillin/sulbactam (ams) and cefepime (fep) were reported as susceptible.The expected result for these drugs was resistant.The strain was submitted for investigation.The submitted strain was subcultured, and the identification was confirmed as e.Coli.Testing was performed on vitek 2 ast-gn70 cards from the customer lots (5900727403, 5900755403) and a random lot (5900650403), as well as agar dilution (ad) as the reference method for fep02n and sam01n formulations found on this card.Clsi breakpoints: ams /= 32 (r) fep /=16 (r) ampicillin/sulbactam mics = 8 (s), 4 (s), >/=32 (r) on the three(3) vitek 2 gn70 cards tested.Ams ad mic =32 (r).Cards and reference method are in agreement for one (1) card, and essential agreement error for the other two (2) cards, demonstrating a very major error for the vitek 2.Cefepime mics

• 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; hazelwood MO 63042
• MDR Report Key: 7914595
• Report Number: 1950204-2018-00395
• Device Sequence Number: 19396904
• Product Code: LON
• UDI-Device Identifier: 03573026398477
• UDI-Public: 03573026398477
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 12/07/2018

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: 12/21/2019
• Device Catalogue Number: 413401
• Device Lot Number: 5900755403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018; 11/13/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 09/27/2018; 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1