MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® REVEAL¿ SENSOR PANEL

Catalog Number	900-00002
Medical Device Problem Codes	Unable to Obtain Readings (1516); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the reveal ast system is an in-vitro diagnostic (ivd) automated system for antimicrobial susceptibility testing of organisms direct from positive blood culture.The reveal ast assays are indicated for susceptibility testing of specific pathogenic bacteria commonly associated with or causing bacteremia as well as bacterial isolates from other specimen types.Results are intended to be used in conjunction with gram stain, organism identification and other clinical laboratory findings.Issue description: a customer in spain notified biomérieux of ¿no ast results¿ issues in association with vitek® reveal¿ sensor panel (20 tests) (ref.900-00002, lot.2025-06-10) results are summarized below: 1.Ast__20250520_1311__r205__a1__lf there is no result for the antibiotics aztreonam, ceftolozane -tazobactam and imipenem.The sample is blood culture that was processed withing the next 2 hours after reported positive.The lot numbers are 101724gwa for the sensor and 2025-06-10 for the panel at the time of the global assessment, biomérieux global customer service did not get the data from the customer to determine the root cause of the issue.
Additional Manufacturer Narrative
The customer complaint associated with this mdr was initially documented against the vitek® reveal¿ sensor panel (20 tests) (ref.900-00002).This product is registered with fda under 510(k) k230675.During investigation of the reported event, it was subsequently determined the complaint was in fact related to vitek® reveal¿ gn01-ast (20 tests) - 900-00008.This product is an export-only product that is not registered with fda, and is not distributed in the united states.Therefore the event is not reportable to fda.This supplement report serves to close this record.

• Brand Name: VITEK® REVEAL¿ SENSOR PANEL
• Common Device Name: VITEK® REVEAL¿ SENSOR PANEL
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum rd; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum rd.; hazelwood MO 63042
• Manufacturer Contact: céline lacroix-gimon ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 22307047
• Report Number: 1950204-2025-00002
• Device Sequence Number: 20817561
• Product Code: LON
• UDI-Device Identifier: 00860007326929
• UDI-Public: 00860007326929
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K230675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Catalogue Number: 900-00002
• Device Lot Number: 101724 GW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown