MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO OMNIS

Model Number	GI100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The united kingdom pathologist reported the event of "no staining for b-catenin".The test section was found negative at the initial hospital.This case was then sent to another hospital that carried out b-catenin and the test section showed positive nuclear staining.Controls stained correctly.Diagnostics were not altered.No harm or patient impact was indicated.
Additional Manufacturer Narrative
Investigation is currently ongoing.No additional information has been made available.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.
Event or Problem Description
Additional information was received that the log files did not show any instrument anomalies which could have caused the reported issue.It has not been possible to gather any additional information from the customer to support further investigation.Root cause of this problem could not be identified.
Additional Manufacturer Narrative
G3: date received by manufacturer was updated with correct information.

• Brand Name: DAKO OMNIS
• Common Device Name: DAKO OMNIS
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, 76892 3; SN 768923
• Manufacturer (Section G): SHANDON DIAGNOSTICS LIMITED; tudor road; manor park; runcorn, WA7 1 TA; UK WA7 1TA
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 16626140
• Report Number: 3003423869-2023-00045
• Device Sequence Number: 4551204
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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 Model Number: GI100
• Device Catalogue Number: GI10030
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023; 04/12/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/24/2023; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown