MAUDE Adverse Event Report: DAKO DENMARK APS DAKO OMNIS

Model Number	GI100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Summary: based on complaint report or investigated failure mode, there was an alteration in staining.Customer complaint record reported the event as follows: weak to no staining.No direct or indirect patient harm or user harm have been reported.

• Brand Name: DAKO OMNIS
• Common Device Name: DAKO OMNIS
• Manufacturer (Section D): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA 2600
• MDR Report Key: 10538554
• Report Number: 9610099-2020-00008
• Device Sequence Number: 3580794
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other