MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC. AUTOSTAINER LINK 48

Model Number AS480

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 08/10/2020

Event Type  malfunction  

Event Description

Based on complaint report or investigated failure mode, there was an alteration in staining.Customer complaint record reported the event as follows: false negative no direct or indirect patient harm or user harm have been reported.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOSTAINER LINK 48
• Manufacturer (Section D): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria, ca
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria, ca
• Manufacturer Contact: mani siravanta ; 6392 via real; carpinteria, ca ; 5665462
• MDR Report Key: 10478697
• MDR Text Key: 207383060
• Report Number: 2022180-2020-00321
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AS480
• Device Catalogue Number: AS48030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2020
• 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
• Patient Outcome(s): Other