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

Catalog Number	K5207
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HERCEPTEST FOR THE DAKO AUTOSTAINER
• Manufacturer (Section D): DAKO DENMARK A/S; produktionsvej 42; glostrup, 2600 ; DA 2600
• MDR Report Key: 7598042
• Report Number: 9610099-2018-00002
• Device Sequence Number: 11201242
• Product Code: MVC
• UDI-Device Identifier: 05700572031994
• UDI-Public: 05700572031994
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P980018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: K5207
• Device Lot Number: 20029667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other