MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. BENCHMARK XT STAINING MODULE

Model Number 05265231001

Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339); Inaccurate Dispensing (2955)

Patient Problems Test Result (2695); Cancer (3262)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

Customer diagnosed a negative pt resulting using cytokeratin 5/6 on (b)(6) 2014, using benchmark xt.Pt was prescribed for therapy.On (b)(6) 2017 customer aborted further staining runs after realizing they had negative results from the (b)(6).

Manufacturer Narrative

Ventana med sys inc received replacement instrument parts back for analysis.A rep retained sample of cytokeratin 5/6 was used.The parts and the regent kit are performing as labeled.Investigation will conclude in the next few days.No failure mode has been identified.The regent kit the customer was using has not been returned for evaluation.Pt is on corret therapy according to the customer, and adverse effects have been reported to the mfr.Returned part evaluation shows no instrument-related contribution to the negative result at this time.Roche service organization will encourage the customer to conduct timely pre-checks of all necessary parameters before running.The customer is reported to be running normally now.The pt is reported to be on correct therapy.

• Brand Name: BENCHMARK XT STAINING MODULE
• Type of Device: BENCHMARK XT
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.
• Manufacturer Contact: 1910 east innovation park dr.; tucson, AZ 85755-1962 ; 5208777239
• MDR Report Key: 4038065
• MDR Text Key: 4844818
• Report Number: 2028492-2014-00003
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 05265231001
• Other Device ID Number: 04015630981069 GTIN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2014
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2006
• Type of Device Usage: Initial
• Patient Sequence Number: 1