MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An abbott employee reported a splash to the face while performing maintenance on the alinity s processing module.While cleaning the sample probe wash station with a brush, saline was sprayed off the brush, and droplets entered the employee¿s mouth.The employee flushed her oral cavity with water.The employee was treated for possible exposure to infectious material at the emergency department with an examination by the attending physician and routine bloodwork.There was no other further follow up.There was no further impact to patient management or user safety reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
An abbott employee reported a splash to the face while performing maintenance on the alinity s processing module.While cleaning the sample probe wash station with a brush, saline was sprayed off the brush, and droplets entered the employee¿s mouth.The employee flushed her oral cavity with water.The employee was treated for possible exposure to infectious material at the emergency department with an examination by the attending physician and routine bloodwork.There was no other further follow up.There was no further impact to patient management or user safety reported.
Additional Manufacturer Narrative
The abbott ambassador reported that while performing a preventive maintenance procedure on the alinity s system, serial number (b)(6), saline residue was inadvertently sprayed into the oral cavity while cleaning the wash station: sample idh with a brush.The wash station: sample idh was determined to be the issue.Return testing was not completed as returns were not available.A review of the service history for (b)(6) identified no contributing factors to the current complaint and no additional occurrences related to saline residue being inadvertently sprayed into the oral cavity have been reported.A review of complaint and trending data for the alinity s processing module did not identify any similar issues for splashing as described in this complaint.Additionally, review of complaint and trending data associated with the wash station: sample idh (part number b-30103523-01) did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the alinity s processing module for serial (b)(6) or the wash station: sample idh was identified.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22027659
• Report Number: 1628664-2025-00004
• Device Sequence Number: 8111997
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BL125674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WASH STATION: SAMPLE IDH, B-30103523-01, UNKNOWN.; WASH STATION: SAMPLE IDH, B-30103523-01, UNKNOWN.
• Patient Sex: Unknown