MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48; AUTOMATED SLIDE STAINER

Model Number	AS480
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to a field service engineer that there was a spill of non-hazardous waste liquid onto the customer's laboratory counter when tubing on the side of the autostainer instrument disconnected.The tubing locks into the device but was disconnected for unknown reasons causing the spill of fluid onto the counter and onto their power strip while plugged into the electrical outlet.Previous service visits confirmed the tubing was locked in place.The technician panicked and began to wipe the liquid from the power strip while not wearing gloves or personal protective equipment.The technician felt a slight electric shock and experienced a brief tingling sensation in their hand.Following the shock, the technician was seen by a healthcare professional as a precaution, without any issues noted and no medical treatment was administered.Follow-up information also confirmed that no further medical intervention was required.Although requested, no other information was provided on how the tubing became unlocked, and the device remains fully operational.The autostainer basic user guide provides clear safety instructions including both: "eye protection and gloves must be worn when handling any of the reagents, bulk liquids or wastes," and "do not touch electrical components with wet or damp hands." although the device did not malfunction, this report is being filed as part of due diligence to report all information that is reasonably known at the time of the event.Should more information become available for this event, a supplement report will be submitted.

• Brand Name: AUTOSTAINER LINK 48
• Common Device Name: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: benjamin gaither ; 1834 state highway 71 west; cedar creek, TX 78612 ; 5123328207
• MDR Report Key: 22986914
• Report Number: 3003423869-2025-00044
• Device Sequence Number: 8918520
• Product Code: KPA
• UDI-Device Identifier: 05700571112571
• UDI-Public: (01)05700571112571(11)221128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AS480
• Device Catalogue Number: AS48030
• 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: 08/07/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown