MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC AUTOSTAINER SLIDE RACKS; AUTOSTAINER SLIDE RACKS - KPA

Catalog Number S3704

Device Problem Lack of Maintenance Documentation or Guidelines (2971)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

As part of dako's continuous improvement process, capa (b)(4) was raised to update the dako autostainer user guide regarding a known issue, slide racks out of level failures.Capa (b)(4).

Event Description

Summary: this report is regarding autostainer slides racks used with dako autostainer link instruments, an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates.The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the autostainer link automated workstations operating either singly or in networked configurations.(b)(6) has identified an additional correction to the risk of slide rack leveling failures as described in the current autostainer user guides.Such failures have the potential to impact staining quality with weak/uneven staining, which may lead to false negative test results.We are updating the autostainer link basic user guide to include an additional mitigation to the slide rack leveling risk.Slide racks may be affected by repeated exposure to the heat of the hot water bath of the pt link leading to the risk of level failures.We have determined that a limit of 175 uses of each slide rack will further reduce the risk of out-of-level slides.Following this update to the guide will ensure that the slide racks are not used beyond their ability to withstand the hot water bath and are replaced at a frequency appropriate for the customer's workflow.Clinical significance: if use of slide racks is in excess of 175 pt link pre-treatment cycles, then there is the possibility that out-of-level slide racks may lead to weak/uneven staining, which potentially leads to false negative test results and may impact patient treatment.If on-slide controls are run, as recommended by the autostainer user guide, the failure would be detected.In conclusion, if our recommendations, stated in the current autostainer user guide, are followed, the likelihood of risk to patients is remote.

Event Description

Summary: this report is regarding autostainer slides racks used with dako autostainer link instruments, an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates.The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the autostainer link automated workstations operating either singly or in networked configurations.Agilent has identified an additional correction to the risk of slide rack leveling failures as described in the current autostainer user guides.Such failures have the potential to impact staining quality with weak/uneven staining, which may lead to false negative test results.We are updating the autostainer link basic user guide to include an additional mitigation to the slide rack leveling risk.Slide racks may be affected by repeated exposure to the heat of the hot water bath of the pt link leading to the risk of level failures.We have determined that a limit of 175 uses of each slide rack will further reduce the risk of out-of-level slides.Following this update to the guide will ensure that the slide racks are not used beyond their ability to withstand the hot water bath and are replaced at a frequency appropriate for the customer's workflow.Clinical significance: if use of slide racks is in excess of 175 pt link pre-treatment cycles, then there is the possibility that out-of-level slide racks may lead to weak/uneven staining, which potentially leads to false negative test results and may impact patient treatment.If on-slide controls are run, as recommended by the autostainer user guide, the failure would be detected.In conclusion, if our recommendations, stated in the current autostainer user guide, are followed, the likelihood of risk to patients is remote.

Manufacturer Narrative

Final follow up: the fsca/recall was completed in april 23, 2019 for all 74 countries.Effectiveness for all countries: 100% (74 out of 74) of the subsidiaries and distributors have responded to the fsn.For all customers, who did not respond to the fsn, three good faith effort attempts to contact the customers have been conducted, with at least one attempt in writing.100% customers have either responded to the fsn or were closed by good faith effort.Fsca was finalized in eua: march 25, 2019.Final effectiveness of eua: 81 % of the customers have responded to the fsn.19 % of the customers were closed by good faith effort.Attachment: [hha capa00729.Pdf, capa00729- us affected customers.Xls, fsca strategy signed 14.01.Docx.Pdf, capa00729 field safety notice - final.Pdf].

• Brand Name: AUTOSTAINER SLIDE RACKS
• Type of Device: AUTOSTAINER SLIDE RACKS - KPA
• Manufacturer (Section D): DAKO NORTH AMERICA, INC; 6392 via real; carpinteria CA 93013
• MDR Report Key: 8243832
• MDR Text Key: 134584834
• Report Number: 2022180-2019-00001
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S3704
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other