MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 AST-GP67 TEST KIT; VITEK® 2 AST-GP67 TEST KIT

Catalog Number	22226
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 result for staphylococcus aureus while testing a patient isolate using the vitek® 2 ast-gp67 test kit (reference #22226, lot # 1321260213).Ast-gp67 results: cefoxitin screen: positive.Oxacillin: mic = 0.5.Alternate method results: pbp2a: negative.No repeat testing was performed.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of obtaining a false positive cefoxitin screen result for staphylococcus aureus while testing a patient isolate using the vitek® 2 ast-gp67 test kit (reference #22226, lot # 1321260213).The customer's isolate was not able to be submitted for investigational testing.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.A review of complaints did not indicate a trend for this card lot.Vitek 2 ast-gp67, lot 1321260213 met final qc release criteria.The lot passed qc performance testing.No further investigation could be performed without the isolate for investigational testing.See h10 for addtl mfg narrative.

• Brand Name: VITEK 2 AST-GP67 TEST KIT
• Common Device Name: VITEK® 2 AST-GP67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9882339
• Report Number: 1950204-2020-00100
• Device Sequence Number: 2320492
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321260213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1