MAUDE Adverse Event Report: bioMerieux Inc. VITEK 2 COMPACT 30 - 27530

Catalog Number	27530
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: VITEK 2 COMPACT 30 - 27530
• Common Device Name: VITEK 2 COMPACT 30 - 27530
• Manufacturer (Section D): bioMerieux Inc.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): bioMerieux Inc.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: stefania ciranda ; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• MDR Report Key: 50257523
• Report Number: 1950204-2026-00008
• Device Sequence Number: 10629788
• Product Code: LON
• UDI-Device Identifier: 03573026136789
• UDI-Public: 03573026136789
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050002
• 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
• Report Date (Section B): 08/14/2026

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: 27530
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/14/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown