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

Model Number AS480

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

As part of agilent's continuous improvement process, our procedures were reviewed and it was determined that there is a need to report potential risks associated with critical liquid dispense system components on the autostainer.We have assessed all autostainer dispense and leakage complaints from november of 2017 through march of 2020 that resulted in alteration in staining or potential alteration in slide staining.Following this review, it was decided to retrospectively file an mdr for customer complaint (b)(4).This is an initial report.Summary: based on complaint report or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: false negative staining on multiple assays no direct or indirect patient harm or user harm have been reported.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOSTAINER LINK 48 INSTRUMENT SYSTEM
• 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: 10370265
• MDR Text Key: 203512691
• Report Number: 2022180-2020-00109
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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: 01/14/2020
• 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
• Patient Outcome(s): Other