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

Catalog Number	415670
Medical Device Problem Code	False Positive Result (1227)
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 a quality control failure, false positive cefoxitin screen test for s.Aureus atcc® 29213¿ strain in association with vitek® 2 ast-gp75 test kit 20 cards ¿ (ref.415670), lot.#2751438113.The expected result is cefoxitin screen negative.It should be noted that this customer already reported the same qc failure for this atcc strain using a different lot.Gcs (global customer service) suggested to the customer to repeat testing with the following recommendations: clean the optics of the instrument.Obtain a new cultiloop.Streak to sba and incubate in 35 degrees celsius in co2.Check for purity.Repeat streak to sba for 24 hours.Place on the instrument.Repeat testing following those recommendations still resulted in qc failure.Therefore, the optics were changed at the customer site and since this replacement, the customer does not encounter the issue anymore.There is no patient associated with this qc isolate; therefore, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding false positive cefoxitin screen (oxsf) test for s.Aureus atcc® 29213¿ strain in association with vitek® 2 ast-gp75 test kit 20 cards ¿ (ref.(b)(4), lot 2751438113.No lab reports, troubleshooting information, nor the strain was available for investigation evaluation.Internal testing was conducted using cards from the customer's lot and a random lot of ast-gp75 cards, 2751494403, in duplicate.Testing was conducted using the internal biomérieux staphylococcus aureus atcc strain 29213 (694).Testing on all of the cards resulted in the expected negative oxsf results.The customer's false positive oxsf result was not reproduced when testing from the biomérieux internal qc strain.Vitek® 2 ast-gp75 lot 2751438113 met final qc release criteria.In addition, the customer had their reader optics replaced by a field service engineer (fse), and has experienced no additional issues.See section h10.

• Brand Name: VITEK 2 AST-GP75 TEST KIT
• Common Device Name: VITEK® 2 AST-GP75 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11113377
• Report Number: 1950204-2021-00001
• Device Sequence Number: 19821036
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 01/26/2021

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: 11/03/2021
• Device Catalogue Number: 415670
• Device Lot Number: 2751438113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1