MAUDE Adverse Event Report: DAKO DENMARK APS 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	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: alteration of assay and staining in this case has not been confirmed at this time.The problem has yet to be investigated by a field service engineer, and it is unknown if a field service engineer will be able to assess the complaint.This investigation thus far has yet to identify any instrument malfunction or alteration in instrument performance.In the event that a root cause is identified, this new information will be provided via a supplemental report.Failure mode description: as no malfunction has been found as investigation is ongoing; the failure mode could not be verified as an instrument or product specific malfunction.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: weak or absent 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: 10796215
• Report Number: 9610099-2020-00037
• Device Sequence Number: 19571671
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (Y/N): Y
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1