MAUDE Adverse Event Report: Abbott Laboratories Alinity hs Slide Maker Stainer Module; Slide Stainer, Automated

Catalog Number	09P69-01
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a spark from a wire behind the stain baths of the alinity hs processing module while removing the baths for cleaning that occurred overnight.After replacing the baths, the customer observed the spark again from the same wire.No impact to patient management and no impact to user safety was reported.
Additional Manufacturer Narrative
The field service representative was attempting to replicate the scenario when troubleshooting the issue but was unable to replicate.Further troubleshooting service found cables trapped around stain bath drawer rails and removed the cables to inspect for damage but found no damage.Service adjusted the cables, but no parts were replaced.The instrument was verified to be functional after cables were adjusted.The instrument service history for the alinity hs processing module, serial number (b)(6) verifies no subsequent complaints have been reported related to observed electrical sparks.A review of complaint and trending data for the alinity hs processing module did not identify any similar issues related to the current issue.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Based on the available information, no systemic issue or deficiency of the alinity hs processing module for serial number (b)(6) was identified.

• Brand Name: Alinity hs Slide Maker Stainer Module
• Common Device Name: Slide Stainer, Automated
• 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 ; +49()6122582960
• MDR Report Key: 50541584
• Report Number: 3016438761-2026-00483
• Device Sequence Number: 10225369
• Product Code: KPA
• UDI-Device Identifier: 00380740138868
• UDI-Public: (01)00380740138868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/14/2026

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: 09P69-01
• 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: 08/24/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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