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	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the underlying cause of the staining alteration has yet to be investigated by the research and development team.In the event that a root cause is identified, it will be provided through a supplemental medical device report.Failure mode description: as the investigation is ongoing; the root cause could not be verified at this time.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.
Event or Problem Description
Customer complaint record reported the event as follows: false positive control on one slide.No direct or indirect patient harm or user harm have been reported.
Event or Problem Description
Customer complaint record reported the event as follows: false positive control on one slide.No direct or indirect patient harm or user harm have been reported.
Additional Manufacturer Narrative
Additional information: h6.Root cause: after investigation by the research and development team, no root cause was identified.In this event, there was no risk to the patient as the staining aberration was detected by controls and test result was invalidated.Failure mode description: the root cause could not be verified at this time.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.

• 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
• MDR Report Key: 11932897
• Report Number: 3003423869-2021-00232
• Device Sequence Number: 11511874
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1