MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC DAKO; FLEX MONOCLONAL MOUSE (WT1) PROTEIN CLONE 6F-H2, RTU, LINK

Model Number IR055

Device Problem False Positive Result (1227)

Patient Problems Misdiagnosis (2159); Anxiety (2328)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2015, dako received a complaint regarding the routine use of the flex monoclonal mouse anti-human wilms' tumor 1 (wt1) protein clone 6f-h2 on the autostainer link 48 for diagnostic use.Initially the customer reported false positive staining, claiming that this staining contributed to a diagnostic error leading to distress, unnecessary surgery and other incorrect treatment.On august 12, 2015, dako received follow up information regarding this incident.The customer reported that they have revalidated the same batch of wt1 used in the original testing and have confirmed expected staining results.The customer reported that a retest was also carried out at another laboratory, on sections from the same biopsy, and results were also positive.The customer reported that a separate test can on surgical test resection tissue done at another hospital was negative.The customer reported that as a result of these conclusions, the customer has informed dako that they are no longer pursuing a complaint about dako regarding false positive staining with the wt1 antibody.Dako is in the process of obtaining details of this complaint for further investigation.

Manufacturer Narrative

Follow-up: after further investigation, dako has discovered that the problem complaint described in this mdr, 2022180-2015-0002, had nothing to do with the wt1 antibody.The issue was discovered to be related to the envision flex+ product problem that was outlined in mdr 9610099-2015-2015.This investigation is closed.

Event Description

Please see additional manufacture narrative.

• Brand Name: DAKO
• Type of Device: FLEX MONOCLONAL MOUSE (WT1) PROTEIN CLONE 6F-H2, RTU, LINK
• 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: ashleigh dawley ; 6392 via real; carpinteria, CA 93013 ; 8055663072
• MDR Report Key: 5004603
• MDR Text Key: 23089775
• Report Number: 2022180-2015-00002
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: IR055
• Device Catalogue Number: IR055
• Device Lot Number: 10086975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2014
• 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