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

Model Number AS480

Device Problem False Negative Result (1225)

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

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: potential alteration of staining in this case was due to improper operation of the slide rack.The problem was solved by field service engineer with repair of the part.Following the repair, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a slide rack malfunction or if the part stops working; the resulting failure modes could occur.Slide level is out of specification due to rack is bent / warped, parts broken, or instrument and/or sink level is out of calibration.These failure modes have the potential to alter staining.

Event Description

Based on complaint report or investigated failure mode, there was a staining alteration.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 93013
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer Contact: benjamin gaither ; 6392 via real; carpinteria, CA 93013 ; 5123328207
• MDR Report Key: 10838714
• MDR Text Key: 220965147
• Report Number: 2022180-2020-00386
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): Y
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1