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

Catalog Number	22226
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A biomérieux internal investigation has been completed.The isolate was accepted for investigation and testing was conducted with cards from the customer¿s lot (1321260213) and a random lot (1321329403), both in duplicate.Reference and alternative methods included oxacillin agar dilution, broth microdilution, cefoxitin disc diffusion and pbp2a testing.Identification of the isolate as staphylococcus aureus was confirmed by vitek ® ms.All four cards tested yielded negative cefoxitin screen and susceptible oxacillin results (mic = 0.25 x4).Reference and alternative method testing provided the following results: oxacillin agar dilution: mic = 0.5 (s), broth microdilution: mic = 0.5 (s), cefoxitin disc diffusion: 18 mm (r), and pbp2a: pos.The vitek ® 2 results are in essential and categorical agreement with both the oxacillin agar dilution and broth microdilution reference methods.However, the vitek ® 2 results are not in agreement with the cefoxitin disc diffusion and pbp2a results.The positive cefoxitin disc diffusion and pbp2a results are indicative of a resistance mechanism governed by the meca gene.A review by r&d showed that the growth in the drug wells was consistent with the oxacillin and cefoxitin screen results observed, that is, there was no growth in the cefoxitin screen wells and little to no growth in the oxacillin wells.The customer¿s non-detection of mrsa was reproduced.The isolate will be added to the r&d stock collection.The vitek® 2 ast-gp67 cards, lot 1321260213, met final qc release criteria.The lot passed qc performance testing.
Event or Problem Description
A customer in the united states notified biomérieux of a false negative cefoxitin screen (oxsf) result for staphylococcus aureus in conjunction with the vitek 2 ast-gp67 test kit (ref.22226, lot 1321260213).In addition, the associated oxacillin result was false susceptible (mic <=0.25).Repeat test obtained the same results.Alternate method testing via pbp2a and biofire bcid provided results of "positive".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.

• 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: 9883386
• Report Number: 1950204-2020-00112
• Device Sequence Number: 14033557
• 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
• Report Date (Section B): 03/26/2020

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
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1