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 05/05/2021

Event Type  malfunction  

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 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 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.

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
• 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
• MDR Report Key: 11932897
• MDR Text Key: 256210248
• Report Number: 3003423869-2021-00232
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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
• Date Manufacturer Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1