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

Catalog Number	06P16-01
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
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 abbott ambassador observed a spark originating from the sample manager icb during quarterly maintenance of the alinity s system.Following the spark, the system generated error codes 5120-b715 (sample manager (b)(4)) sensor failed, and 5120-b715 (sample manager icb (b)(4)) sensor failed.No injuries or harm to the user were reported, and there was no impact to patient management.
Event or Problem Description
The abbott ambassador observed a spark originating from the sample manager icb during quarterly maintenance of the alinity s system.Following the spark, the system generated error codes 5120-b715 (sample manager icb-stepperpg 36v) sensor failed, and 5120-b715 (sample manager icb ¿ stepperflt 36v) sensor failed.No injuries or harm to the user were reported, and there was no impact to patient management.
Additional Manufacturer Narrative
The ambassador completed preventive maintenance on an alinity s system, serial number (b)(6).A spark was observed by the sample manager integrated circuit board (icb) at component j20 when powering the instrument back on and message codes were generated.The ambassador determined the assy rcps spin motor and cable - rcps devices were the cause of the issue.The replacement of the parts resolved the issue.A review of the instrument service history identified no contributing factors to the current complaint.A review of the complaint and trending data identified no trends for the parts or the alinity s instrument with regards to the issue in the current complaint.The device history record was reviewed, and no nonconformances, potential nonconformances or deviations were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the alinity s system, serial number (b)(6).

• 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: 23199862
• Report Number: 1628664-2025-00007
• Device Sequence Number: 21347608
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 09/18/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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
• Patient Sex: Unknown