MAUDE Adverse Event Report: VENTANA/ROCHE VENTANA; IHC DISPENSER KIT

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Event Description

Ventana detection kit dispenser has been malfunctioning for ihc antibodies, not limited to lot numbers or staining platform.Multiple anatomic lab locations have been experiencing staining failures, and potential false negative immunohistochemical stain results.Several complaints have been places with ventana, however, no resolution has been provided by the company.As well as no notification from the company that there has been changes or they are aware of the issues.We were told by our ventana service rep that a resolution would be provided to our company by early december.All ihc antibodies performed using the ventana detection and the ulta and xt ventana instruments.Happening at multiple locations ((b)(6)) in our company.Reached out to other laboratories such as (b)(6), who are also experiencing the same problem.

• Brand Name: VENTANA
• Type of Device: IHC DISPENSER KIT
• Manufacturer (Section D): VENTANA/ROCHE; tucson AZ
• MDR Report Key: 7142055
• MDR Text Key: 95756342
• Report Number: MW5074172
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other