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	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported that they felt a minor shock while going through the cables on the alinity ci-series system control module.The customer indicated that the power went out in the laboratories and the waste pump was not plugged into the ups.Additionally, the scm power supply was also not connected, and therefore there was no touch screen display on the monitor.This caused the instrument to keep running and the waste pump overflowed on the floor.The customer received the minor shock when trying to power off the analyzer.The customer confirmed no treatment was required and was unable to determine if it was an electrical shock vs a static shock.No further impact to patient management.
Additional Manufacturer Narrative
The customer reported receiving a minor shock from the alinity ci-series system control module when investigating where the waste pump power cable was connected and touching an extension cord outlet after pump overflow.No medical treatment was administered.The instrument service history review of (b)(6) found no contributing factors on or around the date of the incident was identified.A review of historical data revealed no systemic issues or nonconformances applicable to the current complaint.Manufacturing documentation did not identify any issues associated with the complaint issue.The alinity ci series operations manual provides adequate information regarding electrical hazards and for the emergency shutdown of the alinity c processing module and the alinity i processing module.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or product deficiency was identified for the alinity ci-series system control module (03r70-01) serial number (b)(6).
Event or Problem Description
The customer reported that they felt a minor shock while going through the cables on the alinity ci-series system control module.The customer indicated that the power went out in the laboratories and the waste pump was not plugged into the ups.Additionally, the scm power supply was also not connected, and therefore there was no touch screen display on the monitor.This caused the instrument to keep running and the waste pump overflowed on the floor.The customer received the minor shock when trying to power off the analyzer.The customer confirmed no treatment was required and was unable to determine if it was an electrical shock vs a static shock.No further impact to patient management.

• 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: 24038276
• Report Number: 3016438761-2026-00023
• Device Sequence Number: 21096888
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K230790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 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: 01/02/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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
• Patient Sex: Unknown