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

Catalog Number 415670

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of false positive (resistant) cefoxitin screen results for staphylococcus aureus atcc® 29213¿ while performing internal quality control testing with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2751392103).Initial and repeat analysis obtained positive (resistant) cefoxitin screen results.Vitek® 2: cefoxitin screen = positive (resistant).Expected: cefoxitin screen = negative (susceptible).Troubleshooting performed by local customer service (lcs) provided the customer with some suggestions for improving their set up, but the cefoxitin screen results obtained were still positive (resistant).A field service engineer (fse) visited the customer's site on 20aug2020 and replaced the optics on the vitek® 2 instrument.The customer performed additional quality control testing with lot 2751392103 after the fse replaced the optics and obtained false positive cefoxitin screen results.As this discrepancy occurred during quality control testing, there is no patient involved.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states regarding false positive (resistant) cefoxitin screen (oxsf) for staphylococcus aureus atcc® 29213¿ while performing internal quality control testing with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2751392103).After troubleshooting, the onsite field service engineer (fse) changed the optics.The customer obtained a new dispensette and autoclaved the one in use, and the issue was resolved.Since the issue was resolved, the customer did not submit the strain; the internal qc strain was tested instead for the biomerieux internal investigation.The internal s.Aureus atcc 29213 strain was subbed and tested on the customer¿s lot and a random lot of ast-gp75 cards (2751494403), in duplicate.On all cards tested, the expected negative oxsf results were obtained.Additionally, no other qc deviations occurred on any card tested.Cards were performing as expected for this qc strain.The customers issue was not reproduced.Vitek 2 ast-gp75 lot 2751392103 met final qc release criteria and passed qc performance testing.See section h10.

• Brand Name: VITEK 2 AST-GP75 TEST KIT
• Type of Device: VITEK® 2 AST-GP75 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10514898
• MDR Text Key: 207168217
• Report Number: 1950204-2020-00170
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (y/n): N
• PMA/PMN Number: K053097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Catalogue Number: 415670
• Device Lot Number: 2751392103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1