MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC; ALK

Model Number 06679072001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Cancer (3262)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

The alk package insert (b)(4) and interpretation guide (b)(4) mandate the use of system controls run with all patient samples.The package insert specifically calls out excessive non-specific background staining of glandular epithelial cells, muscle, or lymphoid tissue that interferes with scoring as unacceptable and instructs users that if the positive or negative tissue controls fail to demonstrate appropriate staining or demonstrate a change in clinical diagnostic interpretation, any results with the test specimens should be considered invalid.

Event Description

Allegation of unacceptable staining (commonly referred to as background, non-specific, and/or overstaining) with product alk (d5f3) contributed to a multiple repeat runs which contributed to the tissue sample being exhausted.

Manufacturer Narrative

From the investigation, there were no similar issues escalated against the complaint alk (d5f3) (06679072001) lot g10367.Additionally, retain materials were tested on appendix and alk-fusion positive/negative nsclc.The background, although, higher than a reference lot of material, did not interfere with specific staining of the tumor or lack thereof.It was determined by the rtd lead pathologist that although background was increased from the reference lot, it would not result in a false positive call.The alk interpretation guide addresses background staining and how to properly evaluate the control and patient specimen slides.The guide directs customers to repeat staining if the controls (system level and negative reagent controls) are not acceptable or if the alk-stained slide is not evaluable.The root cause was not identified for the increase in background of certain lots of reagent.However, based on results from multiple comparisons of raw material purified using different purification resins, a modification was incorporated into the purification process for the anti-alk (d5f3) rabbit monoclonal antibody raw material.Specifically, a change in the protein a resin used to purify the anti-alk (d5f3) rabbit monoclonal antibody raw material was implemented.Verification studies were performed and passed.(b)(4).

• Type of Device: ALK
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• MDR Report Key: 7346049
• MDR Text Key: 102715597
• Report Number: 2028492-2018-00006
• Device Sequence Number: 1
• Product Code: PKW
• Combination Product (y/n): N
• PMA/PMN Number: P140025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2019
• Device Model Number: 06679072001
• Device Catalogue Number: 790-4794
• Device Lot Number: G10367
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1