MAUDE Adverse Event Report: BIOMÉRIEUX, INC VITEK 2 AST-P639 TEST KIT; VITEK® 2 AST-P639 TEST KIT

Catalog Number 418662

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining a false positive result for cefoxitin screen while testing a staphylococcus aureus patient strain using the vitek® 2 ast-p639 test kit (reference # 418662, lot # 7391407403).Customer results: all tests p639 lot 7391407403, alternate susceptibility test= not done, repeat test= not done.Isolate 20210112114-1, s.Aureus, cefoxitin screen positive, oxacillin mic=0.5 susceptible-> resistant, modified by advanced expert system¿ (aes).The strain was submitted to biomérieux shanghai for testing: tested two times using customer¿s cards (lot no:7391407403).Tested two times using cards in shanghai lab (lot no:2421208203).Cefoxitin disk diffusion testing and oxacillin mic (agar diffusion).20210112114: staphylococcus aureus.Cefoxitin screen-negative.Oxacillin (mic: 0.5/0.5/0.5/0.5, s), cefoxitin disk diffusion testing: 23/24mm, s.Oxacillin mic: 1, s (4 times).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.

Manufacturer Narrative

This report was initially submitted following notification from a customer in china regarding a false positive result for cefoxitin screen (oxsf) and false resistant result for oxacillin while testing a staphylococcus aureus patient strain using the vitek® 2 ast-p639 test kit (reference # 418662, lot # 7391407403).Customer results: initial test using vitek 2 ast-p639 lot 7391407403.Repeat test = not performed alternate method susceptibility test = not performed.Isolate 20210112114-1, s.Aureus.Cefoxitin screen positive.Oxacillin mic=0.5 (susceptible), modified to resistant by advanced expert system¿ (aes).The biomérieux subsidiary in shanghai obtained the customer¿s strain for testing.The subsidiary tested the isolate twice using the customer¿s cards (lot 7391407403), and twice using cards from the shanghai lab.Cefoxitin disk diffusion testing and oxacillin mic (agar diffusion) were also performed.Cefoxitin screen - negative.Oxacillin mic: 0.5, s (four times).Cefoxitin disk diffusion testing: 23/24mm, s.Oxacillin mic: 1, s (four times).The customer's false positive oxsf was not duplicated.Vitek 2 cards and reference method are in essential agreement.The customer's strain was not submitted to the biomérieux customer response laboratory to test as part of this investigation.Submission of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Vitek® 2 ast-p639 lot 7391407403 met final qc release criteria and passed qc performance testing.The vitek® 2 ast-p639 lot 7391407403 performed in accordance with specification.See section h10.

• Brand Name: VITEK 2 AST-P639 TEST KIT
• Type of Device: VITEK® 2 AST-P639 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11350998
• MDR Text Key: 280447484
• Report Number: 1950204-2021-00018
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: K053097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Catalogue Number: 418662
• Device Lot Number: 7391407403
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1