MAUDE Adverse Event Report: DAKO NORTH AMERICA INC. ARTISAN GOMORI'S BLUE TRICHROME STAIN KIT

Model Number AR167

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: alteration of assay and staining in this case was not confirmed.The problem was investigated by a field service engineer.This investigation did not identify any instrument malfunction or alteration in instrument performance.The instrument remains fully operational within specifications, without errors and available for the user.Failure mode description: as no malfunction were found after completion of investigation; 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 Description

Customer complaint record reported the event as follows: inconsistent staining.No direct or indirect patient harm or user harm have been reported.

• Brand Name: ARTISAN GOMORI'S BLUE TRICHROME STAIN KIT
• Type of Device: ARTISAN GOMORI'S BLUE TRICHROME STAIN KIT
• Manufacturer (Section D): DAKO NORTH AMERICA INC.; 6392 via real; carpinteria CA 93013
• Manufacturer (Section G): DAKO NORTH AMERICA INC.; 6392 via real; carpinteria CA 93013
• Manufacturer Contact: sonia siddique ; 6392 via real; carpinteria, CA 93013 ; 5123328112
• MDR Report Key: 10678730
• MDR Text Key: 213443346
• Report Number: 2022180-2020-00358
• Device Sequence Number: 1
• Product Code: KFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/14/2020

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
• Device Operator: Health Professional
• Device Model Number: AR167
• Device Catalogue Number: AR16792-2
• Device Lot Number: 11161727
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1