MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC; ALK

Model Number 06679072001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

It is unknown if there was a deterioration in patient health.We have asked the customer multiple times with no response.There is no indication of a malfunction with a ventana medical systems instrument or assay.The alk package insert 790-4796 (b)(4) and interpretation guide 790-4796 (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.In addition, the alk interpretation guide provides image examples of unacceptable background staining.Use of tissue controls is also mandated by global quality assurance organizations and quality control guidelines including the clinical laboratory improvement amendments clia regulations.This is the initial and final report.

Event Description

The alk therapy treatment resulted in patient admission to intensive care unit.Additional testing was conducted at second hospital for egfr and alk.There was high back ground staining observed however the doctor at the second hospital was able to read the slide and make the correct negative diagnosis which was confirmed with fish.

• Type of Device: ALK
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• Manufacturer Contact: tim giblin ; 1910 e innovation park dr; na; tuscon, AZ 85755 ; 5208777035
• MDR Report Key: 7303925
• MDR Text Key: 101234691
• Report Number: 2028492-2018-00005
• Device Sequence Number: 1
• Product Code: PKW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: 06679072001
• Device Catalogue Number: 790-4794
• Device Lot Number: Y13568
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1