MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK®2 AST-GN67 TEST KIT

Catalog Number	413399
Medical Device Problem Code	False Negative Result (1225)
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 false negative esbl results associated with vitek®2 ast-gn67 test kit(reference 413399).Repeat testing was conducted on the isolate because the laboratory technicians were questioning the aminoglycoside hierarchy results for gentamicin and amikacin.The gentamycin was intermediate and amikacin was resistant.The microscan results stated the isolate was an esbl which was not reported on the vitek® instrument.The customer repeated the isolate testing on the vitek®2 and microscan and received the same results.The customer did report out on an esbl positive isolate.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: a k.Pneumoniae isolate was submitted for esbl evaluation because the vitek® 2 ast-gn67 card gave negative esbl test results on multiple runs.When the isolate was tested on microscan walkaway, an esbl positive result was obtained.Identification was confirmed, and testing included both the customer lot and a random lot of ast-gn67 cards, run in duplicate.The clsi esbl disk test, which is the reference method, was also performed.On all four (4) card runs, negative esbl test results were obtained.The clsi esbl disk test was also negative.Therefore, the customer's negative esbl test results were duplicated in-house and are in agreement with the reference method.Cards are performing as expected.

• Brand Name: VITEK®2 AST-GN67 TEST KIT
• Common Device Name: VITEK®2 AST-GN67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7442825
• Report Number: 1950204-2018-00146
• Device Sequence Number: 11075816
• Product Code: LON
• UDI-Device Identifier: 03573026398453
• UDI-Public: 03573026398453
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 01/20/2019
• Device Catalogue Number: 413399
• Device Lot Number: 5870420403
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1