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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united sates notified biomérieux of a false positive cefoxitin screen result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref.22226, lot 1321260213).The isolate obtained a positive cefoxitin screen result with a susceptible oxacillin result that was modified to resistant by the advanced expert system (aes).The isolate was retested on the vitek® 2 and using the meca test method; both assays obtained a negative result.The customer confirmed the positive cefoxitin screen result was reported to the treating physician.However, the customer reported that there was no patient harm or incorrect treatment due to the discrepant result.Note: customer report had a comment enabled stating ¿if cefoxitin screen is positive and oxacillin result is susceptible: recheck id and confirm purity ¿ repeat testing ¿ if still inconsistent, confirm with meca test before reporting.¿ biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of a false positive cefoxitin screen result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref.(b)(4), lot 1321260213).The isolate obtained a positive cefoxitin screen result with a susceptible oxacillin result that was modified to resistant by the advanced expert system (aes).The customer submitted the strain for investigational testing.The customer¿s isolate was received and sub-cultured to remel tsab at 35-37c in co2 for 22 hours.After a second sub-culture, the isolate was tested with cards from the customer¿s lot (1321260213) and a random lot (1321123103), both in duplicate.Reference method and alternative tests included oxacillin agar dilution, cefoxitin disc diffusion and pbp2a.The identification of the isolate was confirmed on vitek® ms as staphylococcus aureus.912252: all four cards returned negative cefoxitin screen and susceptible oxacillin (mic = 0.5 mg/l) results.Reference method and alternative testing yielded the following results: oxacillin agar dilution: mic = 0.5 mg/l (susceptible).Cefoxitin disc diffusion: 23 mm (susceptible).Pbp2a: neg.The customer¿s false positive cefoxitin screen was not reproduced and the vitek 2 cards are performing as intended.Ast-gp67, lot 1321260213 met final qc release criteria.The lot passed qc performance 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: 9820672
• Report Number: 1950204-2020-00058
• Device Sequence Number: 19615565
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• 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): 05/01/2020

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: 02/11/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1