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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer was changing the waste pump on the alinity ci series system and noticed a superficial cut on the tip of their left ring finger.The customer was wearing gloves.They washed with soap and was put on triple therapy medication called delstrigo (antiretroviral drug) for one month.The customer was prescribed delstrigo (antiretroviral therapy).There was no further impact to the user/operator reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
A complaint investigation was conducted for the external waste pump associated with alnty ci-series sys cnt serial number (b)(6).The instrument service history review revealed no additional tickets associated with the issue described in the current complaint.A review of tracking and trending did not identify any trends with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.A ¿sharp edges¿ test was performed on the alinity ci external waste pump.The construction was evaluated and found to be compliant to the following requirement: ¿all easily-touched parts of the equipment shall be smooth and rounded so as not to cause injury during normal use of the equipment¿.Additionally, objective testing was performed using calibrated equipment.The test results show only a small indentation and no penetration of the test layers.Therefore, the edge is not considered sharp according to test standards.No malfunction or systemic issue was identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.
Event or Problem Description
The customer was changing the waste pump on the alinity ci series system and noticed a superficial cut on the tip of their left ring finger.The customer was wearing gloves.They washed with soap and was put on triple therapy medication called delstrigo (antiretroviral drug) for one month.The customer was prescribed delstrigo (antiretroviral therapy).There was no further impact to the user/operator reported.

• 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: 23508794
• Report Number: 3016438761-2025-00662
• Device Sequence Number: 18568173
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/28/2026

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?: No
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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: ALNTY CI EXTERNAL WASTE, (B)(6). ; ALNTY CI EXTERNAL WASTE, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown