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	05/13/2021
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 staining.No direct or indirect patient harm or user harm have been reported.
Event or Problem Description
Customer complaint record reported the event as follows: part of slides were not stained.No direct or indirect patient harm or user harm have been reported.
Additional Manufacturer Narrative
Corrected data: d1, d2, d4.
Additional Manufacturer Narrative
Corrected data: d3, g3.Additional information: h6.
Event or Problem Description
Customer complaint record reported the event as follows: part of slides were not stained.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 ; SN 2600
• MDR Report Key: 10511584
• Report Number: 9610099-2020-00003
• Device Sequence Number: 19709780
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2021

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: 08/06/2020
• Supplement Date Received by Manufacturer: 05/13/2021; 05/13/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 05/27/2021; 05/28/2021
• 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