MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R70-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while cleaning the hoses on the external waste pump with an alinity ci-series system control module, an employee was sprayed in the eye with the high-concentration waste hose.It was reported that the individual immediately rinsed with the eyewash station.The individual went to the emergency room and had their eyes examined and laboratory blood work taken.No further treatment or intervention was reported the customer reported that there are no eye complaints for the individual.There was no reported impact to patient management.
Additional Manufacturer Narrative
E1 phone: complete phone number is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Additional information can be found in section b5.The alinity ci-series sys cnt, serial #(b)(6) was evaluated.Tubing for the external waste pump was cleaned.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional complaints associated with the complaint.A review of tracking and trending did not identify an increase in complaint activity for both the alinity system and the alnty ci external waste with regards to the reported event.A review of the manufacturing documentation did not identify any issues as it relates to the alnty ci external waste and reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified.
Event or Problem Description
The customer reported that while cleaning the hoses on the external waste pump with an alinity ci-series system control module, an employee was sprayed in the eye with the high-concentration waste hose.It was reported that the individual immediately rinsed with the eyewash station.The individual went to the emergency room and had their eyes examined and laboratory blood work taken.No further treatment or intervention was reported the customer reported that there are no eye complaints for the individual.There was no reported impact to patient management.Additional information: the individual was wearing protective eye wear at the time of the event.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21654016
• Report Number: 3016438761-2025-00181
• Device Sequence Number: 13072966
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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