MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. PATHYWAY ANTI-HER-2/NEU (4B5) RABBIT MONO; HER2 4B5

Model Number 05278368001

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

Patient Problems Breast Neoplasm (2438); No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2014

Event Type  Injury  

Event Description

On (b)(6) customer conducted a re-test of a breast cancer pt using pathway anti-her-2/neu (4b5) rabbit monoclonal antibody kit.The result was positive, which contradicted an (b)(6) result for the same pt.The mfr confirmed the customer was not using prescribed system controls but rather commercially available 4-in-one slides to be used in validation and troubleshooting.The customer was also found to be using questionable pre-analytical techniques for use of histopathology tissue staining kits (storage or reagents without capping to prevent drying out, use of the kits immediately from the refrigerator without warming up, etc.).

Manufacturer Narrative

Customer is not cooperative in providing the necessary investigational info.Final conclusion is that potentially a user error related to pre-analytical preparation resulted in a negative result in april.At some point a retest was conducted (reasons not disclosed to the mfr) by a 3rd party lab - results conflicted with the earlier test.On (b)(6) the customer repeated their test using a new lot of pathway anti-her-2/neu (4b5) rabbit monoclonal antibody, which resulted in a positive result.Customer has not confirmed any pt related impact, data details, or status.No further details are expected from the customer.This is an initial and final report.

• Brand Name: PATHYWAY ANTI-HER-2/NEU (4B5) RABBIT MONO
• Type of Device: HER2 4B5
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.
• Manufacturer Contact: richard moss ; 1910 east innovation park dr.; tucson, AZ 85755 ; 5208777239
• MDR Report Key: 3987591
• MDR Text Key: 18933399
• Report Number: 2028492-2014-00002
• Device Sequence Number: 1
• Product Code: MVC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 05278368001
• Device Catalogue Number: 790-2991
• Device Lot Number: D09098
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention