MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC BENCHMARK ULTRA

Model Number 05342716001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Breast Cancer (1759); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

The case indicates that while performing pathway her-2 (4b5) testing on a benchmark ultra instrument a patient sample stained negative (on (b)(6) 2017) with appropriate staining of the same slide control tissue.The control tissue was placed towards the top of the slide and the patient sample below that.For unknown reasons, the patient was subsequently tested based on other test types (oncotype and fish) at a 3rd party location and was reported as her2 positive (results received on (b)(6) 2017).The customer then performed another her2 (4b5) test for this patient (on (b)(6) 2017) and the results were positive.The patient sample was also er+/pr+ which are additional markers which are typically run in the panel of tests.The impact to patient care has been asked, but is unknown at this time, which is the reason for filing this mdr.Other negative slides from the same day were repeated with no other discordant results.No other issues were noted for pathway her-2 (4b5) antibody which, along with appropriate staining of the control tissue on the affected slide, suggests that the antibody performed as intended.The root cause for a sporadic false negative staining event, while other tests on the run performed appropriately, is unknown.An initial evaluation of the instrument found a component out of specification.However, after bringing the rtd instrument into specification the customer continues to experience the issue intermittently.Also, during on-site troubleshooting of this issue, the customer encountered a slide on a subsequent run where the control tissue (now placed at bottom of slide) failed to stain as intended with a different antibody (tdt not 4b5).This is suggestive of a slide surface hydrophobicity issue.

Event Description

False negative pathway her-2 (4b5) staining on a patient sample.

• Brand Name: BENCHMARK ULTRA
• Type of Device: ULTRA
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; none; tucson AZ 85755 1962
• Manufacturer Contact: tim giblin ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 5208777035
• MDR Report Key: 6870968
• MDR Text Key: 86418605
• Report Number: 2028492-2017-00004
• Device Sequence Number: 1
• Product Code: MYA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2017

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: Other Health Care Professional
• Device Model Number: 05342716001
• Device Catalogue Number: 750-600
• Other Device ID Number: UDI# 04015630981052
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1