MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST CARDS

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

An internal complaint was initiated following a review of a 2020 scientific publication entitled, "current status of oxacillin-susceptible meca positive staphylococcus aureus infection in shanghai, china: a multicenter study" by liu, j., et al.This study tested 956 s.Aureus isolates recovered from ten different hospitals in shanghai between february 2017 and september 2018.Methicillin-resistant staphylococcus aureus (mrsa) is typically resistant to oxacillin.However, sometimes there are cryptic antibiotic resistant organisms in s.Aureus such as oxacillin-susceptible mrsa (os-mrsa).Oxacillin-susceptible mrsa (os-mrsa) carries the meca or mecc but exhibits the mic of oxacillin in the suscepible range (<=2 mg/ml).While testing isolates with the vitek® 2, methicillin-sensitive staphylococcus aureus (mssa) was interpreted if the results were oxacillin susceptible and a negative cefoxitin screen using vitek® 2 software¿s (version 8.01) advanced expert system¿ (aes).While using the vitek® 2 to identify oxacillin-susceptible meca-positive s.Aureus isolates (os-mrsa), using only the vitek® 2 oxacillin mic, 21 isolates were miscategorized as mssa.- oxacillin mic of 1 or 2 mg/ml (15 isolates) - oxacillin mic of 0.5 mg/ml (5 isolates) - oxacillin mic of <= 0.25 mg/ml (1 isolate) to confirm the oxacillin susceptibility of these 21 isolates, the oxacillin mic was compared to clsi recommended (>= 4 mg/ml, resistant and <= 2 mg/ml, susceptible) reference broth microdilution (rbmd).It was determined that four (4) of the vitek® 2 os-mrsa isolates were confirmed to be oxacillin resistant by rbmd.Therefore, those four false oxacillin susceptible mrsa were excluded.In conclusion, only 17 of 956 were identified as os-mrsa strains.Although the vitek® 2 includes oxacillin mic and cefoxitin screening, 11 of the 17 os-mrsa strains could not be corrected to cefoxitin-resistant.Of these 11 strains, nine (9) were confirmed to be cefoxitin resistant using an alternate referent method of cefoxitin disk diffusion.In closing, the vitek® 2 ast cards produced false negative cefoxitin screen results for 11 os-mrsa strains.It is unknown at this time how many patients were involved with these 11 strains.There is no indication or report from the author(s) of the publication that any discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following review of a 2020 scientific publication entitled, "current status of oxacillin-susceptible meca positive staphylococcus aureus infection in shanghai, china: a multicenter study" by liu, j., et al.The study tested 956 s.Aureus isolates recovered from ten different hospitals in (b)(6) between (b)(6) 2017 and (b)(6) 2018 in association with vitek® 2 ast cards.The vitek® 2 ast cards produced false negative cefoxitin screen results for 11 os-mrsa strains compared to broth microdilution.This case was from an internal complaint (shanghai biomerieux).The customer did not provide strains, lab reports, troubleshooting information, or ast card types used in this study.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.The implicated card types/lot numbers are not available for this investigation, so qc performance review of the lots cannot be performed.

Manufacturer Narrative

In alignment with the most recent fda guidance, "medical device reporting for manufacturers, issued november 8, 2016", biomérieux is submitting this notification to fda to inform the agency of the decision to cease reporting specific vitek® 2 malfunction events after two years of no occurrences associated with death or serious injury.For the specific combinations of product and malfunction type, customer complaints were reviewed over a two year period starting from the date of awareness of the most recent event that was classified as a serious injury or death.For the following malfunction types, this review identified no additional occurrences of being associated with death or serious injury for two years.Product code: lon; reference: multiple; malfunction: false negative cefoxitin screen for staphylococcus aureus; final mdr submitted: 1950204-2020-00190.We wish to inform you that with the completion of our mdr data analysis, we have updated our mdr criteria for vitek 2 product code lon, and will no longer report these malfunction events because they have not caused or contributed to a death or serious injury in the past two years.Moving forward, if biomérieux becomes aware of a death or serious injury event for the malfunctions referenced above, we will report that event to the fda per the fda mdr guidance, and will update our mdr criteria to require reporting the specific associated malfunction as required by this guidance.

• Brand Name: VITEK® 2 AST CARDS
• Type of Device: VITEK® 2 AST CARDS
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10589294
• MDR Text Key: 230503090
• Report Number: 1950204-2020-00190
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 11/05/2020; 01/06/2022
• Supplement Dates FDA Received: 12/05/2020; 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1