MAUDE Adverse Event Report: DAKO DENMARK A/S HERCEPTEST FOR THE DAKO AUTOSTAINER

Catalog Number K5207

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

As part of dako's internal audit and continuous improvement process, dako performed an internal review of complaints beginning with those initiated january 1, 2015.This report is based on that review as complaint (b)(4) was determined to be mdr reportable.It is therefore being filed with the fda retrospectively.This is an initial and final report combined.The investigation for this case was closed in 2016, but during review the case has been reopened and reassessed as part of the internal review.

Event Description

Device involved in this complaint: · k5207, herceptest for dako autostainer.Summary: inconsistent staining on product k5207/herceptest for the dako autostainer, lot no.20029667, resulted in a false negative.The customer reran the patient tissue on the herceptest assay which confirmed the negative test result.The customer also ran a fish test on the patient tissue which resulted in a positive result.No misdiagnosis occurred as the patient was diagnosed according to the fish testing.Assessment: the customer ran a fish on the specific patient tissue after the ihc tissue test and retest resulted as negative for her2.The fish test indicated the tissue was positive.The customer indicated they thought their procedure was the cause of negative tests.A service engineer was sent on site to work with the customer.The service engineer confirmed their procedure.No root cause or likely root cause was identified.The serial number of the autostainer was not recorded in the complaint.As part of its internal review, dako analyzed whether there were any additional complaints logged on the customer's lot number and no other complaints were reported.

• Brand Name: HERCEPTEST FOR THE DAKO AUTOSTAINER
• Type of Device: HERCEPTEST FOR THE DAKO AUTOSTAINER
• Manufacturer (Section D): DAKO DENMARK A/S; produktionsvej 42; glostrup, 2600 ; DA 2600
• Manufacturer (Section G): DAKO DENMARK A/S; produktionsvej 42; glostrup, 2600 ; DA 2600
• Manufacturer Contact: nanna aakard ; produktionsvej 42; glostrup, 2600 ; DA 2600
• MDR Report Key: 7598042
• MDR Text Key: 111455017
• Report Number: 9610099-2018-00002
• Device Sequence Number: 1
• Product Code: MVC
• UDI-Device Identifier: 05700572031994
• UDI-Public: 05700572031994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980018
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K5207
• Device Lot Number: 20029667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2016
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other