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 Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed the waste backed up and water got in the extension cord connected to the non-abbott ups.The ups short-circuited and the instrument shut down.The extension cord which the ups was connected showed signs of smoke, sparks were seen, and a burning smell was detected in the laboratory.The power plug for the alinity ci series scm was also burnt.The power plug was replaced.The instrument was plugged in and confirmed it was working correctly.The technician reconfigured the ups and power outlets to a location away from the waste.There was no harm to the user or impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the alinity ci series system control module, serial number (b)(6).It was determined that the alnty c pwr cn eu (alinity power plug) required replacement which resolved the reported issue.A review of the service history for the alinity ci series system control module, serial number (b)(6), did not identify any additional complaints related to the customer reported event.A review of complaint tracking and trending did not identify an increase in complaint activity for either the alinity ci series system control module, serial number (b)(6), or the alnty c pwr cn eu (alinity power plug) related to the reported event.A review of relevant manufacturing documentation did not identify any issues associated, with the alnty c pwr cn eu (alinity power plug) as it relates to the customer reported event.Review of product labeling concluded that the current issue is adequately addressed.Based on the available information, no systemic issue or product deficiency was identified for the alinity ci series system control module, serial number (b)(6), or the alnty c pwr cn eu (alinity power plug).
Event or Problem Description
The customer observed the waste backed up and water got in the extension cord connected to the non-abbott ups.The ups short-circuited and the instrument shut down.The extension cord which the ups was connected showed signs of smoke, sparks were seen, and a burning smell was detected in the laboratory.The power plug for the alinity ci series scm was also burnt.The power plug was replaced.The instrument was plugged in and confirmed it was working correctly.The technician reconfigured the ups and power outlets to a location away from the waste.There was no harm to the user or 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: 24524964
• Report Number: 3016438761-2026-00118
• Device Sequence Number: 20962950
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 04/17/2026

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: 02/25/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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