MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP75 TEST KIT

Catalog Number	415670
Medical Device Problem Code	False Positive Result (1227)
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 obtaining a false positive cefoxitin screen when testing two staphylococcus aureus patient isolates with the vitek® 2 ast-gp75 test kit (reference # 415670, lot # 2751063103).Upon repeat testing the same results were obtained.Customer lot # 2751063103: oxacillin mic = 0.5, susceptible (modified to resistant by advanced expert system¿) for all 4 results.The customer tested the strains a third time with the same lot (lot # 2751063103) and a second lot (lot # 2751069103).All cefoxitin screen results were negative.Customer lot # 2751063103: oxacillin mic <= 0.25, susceptible.Oxacillin mic = 0.5, susceptible.Second lot # 2751069103: oxacillin mic = 0.5, susceptible.Oxacillin mic = 0.5, susceptible.Alternate testing was performed with pbp2a and results were susceptible.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of false positive cefoxitin screen results when testing two staphylococcus aureus patient isolates with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2751063103).The two strains were no longer viable, so they could not be submitted for investigational testing.Submittal of the isolates is required in order to confirm a vitek® 2 discrepancy compared to the reference methods.Since the strains could not be submitted for investigational purposes, no additional investigation could be completed.Ast-gp75 lot #2751063103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-GP75 TEST KIT
• Common Device Name: VITEK® 2 AST-GP75 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8781718
• Report Number: 1950204-2019-00227
• Device Sequence Number: 1889787
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K053097
• 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): 09/16/2019

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: 10/24/2020
• Device Catalogue Number: 415670
• Device Lot Number: 2751063103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1