MAUDE Adverse Event Report: DAKO DENMARK A/S ENVISION G 2 SYSTEM/AP, RABBIT/MOUSE (PERMANENT RED); ENVISION G|2 SYSTEM/AP, RABBIT/MOUSE (PERMANENT RED)

Model Number K5355

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problem Misdiagnosis (2159)

Event Date 03/01/2016

Event Type  No Answer Provided  

Event Description

(b)(6) hospital complained to dako of weak staining using the visualization system k5355, envision g|2 system/ap, rabbit/mouse (permanent red), which may have led to false negative test results and may have contributed to incorrect patient diagnosis.The hospital used a dako antibody against melan a with the k5355 product (lot 20015008), on the dako omnis platform.The expiration date of lot 20015008 of k5355 was 2015-10-31.The assay in question was apparently run by the customer in 2016; it is possible that expired product was used.Dako is in the process of obtaining the instrument log files from the customer in order to confirm this possibility.According to the ifu for k5355, the visualization system is intended for use in manual staining procedures and with the dako autostainer instruments.Use of the product on the dako omnis has not been validated.The preliminary information suggests that use of expired reagents and/or not following the ifu for the product was the most likely cause of this incident; however additional investigation continues to be conducted to determine the root cause.The investigation is ongoing to determine the root cause.

Manufacturer Narrative

Final follow-up information: root cause the customer mistakenly used visualization system k5355, envision g|2 system/ap, rabbit/mouse (permanent red), on the dako omnis instrument; the detection system is only validated for use on dako autostainer instruments.The customer detected that the staining result was not within specification and found out that the wrong instrument was used for staining with k5355.Corrective actions as result of the investigation: no capa has been raised, since the customer used k5355 in error; this system is validated for use on the dako autostainer instruments and is not validated for use on the dako omnis, which led to the weak staining.

• Brand Name: ENVISION G 2 SYSTEM/AP, RABBIT/MOUSE (PERMANENT RED)
• Type of Device: ENVISION G|2 SYSTEM/AP, RABBIT/MOUSE (PERMANENT RED)
• 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: mani siravanta ; 6392 via real; carpinteria, CA 93013 ; 8055665462
• MDR Report Key: 5544907
• MDR Text Key: 41776281
• Report Number: 9610099-2016-00002
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 04/03/2017

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 Model Number: K5355
• Device Lot Number: 20015008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other