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

Model Number GI100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Event 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.

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 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.

Manufacturer Narrative

G3: date received by manufacturer was updated with correct information.

• Brand Name: DAKO OMNIS
• Type of Device: 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
• MDR Text Key: 312432707
• Report Number: 3003423869-2023-00045
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: GI100
• Device Catalogue Number: GI10030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 02/27/2023; 04/12/2023
• Supplement Dates FDA Received: 04/24/2023; 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1