MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. / ROCHE DIAGNOSTICS OPERATIONS INC. VENTANA ULTRA; SLIDE, STAINER, AUTOMATED

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Ventana medical - ultra hc automated staining platform - tissue sides are staining inconsistently, in a manner that makes the error difficult to recognize and could seriously affect patient results, if it hasn't already.I work in a large reference lab, and about 4 months ago we happened to notice a case where the patient sample was initially strongly positive but, through a communication error, was retested and showed negative staining.Controls worked appropriately but weren't on the same slide as the patient sample initially or when first repeated.Subsequent repeats with the control on the same slide also showed negative staining.At the time we attributed it to the dispenser problems ventana was having, but more tests popped up with inconsistent or a complete lack of staining.This was mostly limited to certain clients who used slides from the same few manufacturers, and only for tests run on the ventana platform.We quickly informed ventana, implemented same slide controls for tests that are rarely positive and unlikely to have internal positive controls.We also started repeating cases where the patient tissue was completely negative to confirm the results.Once this system was in place we saw the staining variability more often, but i don't have exact numbers.Other staining variations include negative control and positive patient, variable staining on both, or staining in control with no staining at all in patient (clear tissue which isn't visible even under microscope).Ventana focused on certain slide brands as the sole cause of the staining variability, but over time i have seen issues with most slide types including the ones we use in-house.Some slide brands have significantly more staining issues than others, but only when stained on the ultra.We haven't observed the same problem on other staining platforms (dako, bond), regardless of slide type.Issue seen with antibodies from all manufacturers, with ultraview and optiview detection kits, and all of our 15 ultra stainers.Supposedly the issue was isolated to our lab, and i felt confident we had put steps in place to catch staining discrepancies.Recently i became aware the problem was more widespread through an online histology group.I was actually shocked to hear how many people across the country had the same issue and were also told slides were to blame.Once i heard we weren't the only ones.I had to report it.We've taken steps that i don't know other labs will have the time or resources to implement, if they even realize the problem.The potential for this to negatively impact thousands of patients can't be ignored.

• Brand Name: VENTANA ULTRA
• Type of Device: SLIDE, STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC. / ROCHE DIAGNOSTICS OPERATIONS INC.
• MDR Report Key: 8460156
• MDR Text Key: 140607777
• Report Number: MW5085279
• Device Sequence Number: 0
• Product Code: KPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1