MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY; IMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY, ANAPLASTIC LYMPHOMA KINASE

Catalog Number 06679072001

Device Problem False Positive Result (1227)

Patient Problems Therapeutic Effects, Unexpected (2099); Test Result (2695)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is currently on-going, and the outcome will be communicated in a follow-up report.The material number for the us-ivd product is: 06785042001.(b)(4).

Event Description

A customer in (b)(6) alleged that a false positive result for alk led to the incorrect treatment of a patient.Ventana anti-alk (d5f3) rabbit monoclonal primary antibody (ventana anti-alk (d5f3)) is intended for laboratory use in the detection of the anaplastic lymphoma kinase (alk) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (nsclc) tissue stained with the benchmark ihc/ish instruments.The product is indicated as an aid in identifying patients eligible for treatment with xalkori® (crizotinib), zykadia® (ceritinib), or alecensa® (alectinib).The customer indicated the patient received a false positive result for alk last year.It was observed that the patient was getting worse with the treatment.It was requested that test be repeated by fish (fluorescence in situ hybridization) and the result was negative.The type of treatment that was initiated is unknown.No further details were provided regarding the patient's condition or their diagnosis.Histological slides have been requested but not provided, and there was mention that the pathologist noticed a granular staining pattern.

Manufacturer Narrative

Although requested, no additional information relating to the patient's condition or diagnosis, or histological slides were provided to further investigate the customer's allegation.Additionally, no kit lot information was indicated.The ventana alk (d5f3) cdx assay interpretation guide for non-small cell lung carcinoma (nsclc) addresses background staining and how to properly evaluate the control and patient specimen slides.The guide directs the customer to repeat staining if the controls (system level and negative reagent controls) are not acceptable or if the alk-stained slide is not able to be evaluated.Per the instructions for use, the clinical interpretation of any positive staining must be evaluated within the context of clinical history, morphology and other histopathological criteria.The clinical interpretation of any staining must be complemented by morphological studies and system-level controls as well as other diagnostic tests.It is the responsibility of a qualified pathologist to be familiar with the antibodies, reagents and methods used to interpret the stained preparation.Staining must be performed in a certified licensed laboratory under the supervision of a pathologist who is responsible for reviewing the stained slides and assuring the adequacy of positive and negative controls.(b)(4).

• Brand Name: ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY
• Type of Device: IMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY, ANAPLASTIC LYMPHOMA KINASE
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC; 1910 e innovation park dr; tucson AZ 85755
• MDR Report Key: 8674703
• MDR Text Key: 147243478
• Report Number: 2028492-2019-00009
• Device Sequence Number: 1
• Product Code: PKW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 06679072001
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1