MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC; BENCHMARK XT

Model Number 05265231001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation into this issue is ongoing.The case states that the customer does not use the manufacturer's required package insert criteria for scoring conventions for the interpretation of pathway her2 (4b5) a detailed summary of the outcome of the investigation will be provided through the final report.

Event Description

Customer is transferring breast work (her2, er and pr) from xt to ultra.Approx 50 cases have been used, some in parallel with current cases, but mostly retrospectively.Six (6) cases have been found to be discordant between the xt and ultra (in each case, what was reported as a her2 1+ on the xt was a 2+ on the ultra).Subsequent ddish testing has shown 2 of these cases to be amplified.One case has already resulted in a change of treatment following mdt meeting on (b)(6) 2017.The impact on patient treatment for the other case is unknown at this time.

Manufacturer Narrative

The customer alleges discordant ven anti-her2/neu (4b5) rm pab-us export (05999570001) results between benchmark xt and benchmark ultra instruments.Discordant results were confirmed subsequent her2 dual ish testing.Based upon the information provided by the customer, there is no indication of any rtd product malfunction.There are potential contributing factors to discordant results: the customer does not use the package insert criteria for scoring conventions for the interpretation of pathway her2 (4b5), nor do they use the package insert recommended protocol for ven anti-her2/neu (4b5), which is likely to be a contributor to the darker staining observed on the slides stained on the customer¿s benchmark ultra.Tumor heterogeneity/ serial sections.Her2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues by marilyn a.Owens, bruce c.Horten, moacyr m.Da silva provides evidence indicating that tumors scoring 1+ by her2 ihc testing may produce amplified gene test results.The package insert for ven anti-her2/neu (4b5) also indicates that tumors scoring 1+ by ven anti-her2/neu (4b5) may produce amplified gene test results.Although requested, no additional information about deterioration of the patients¿ health has been provided.The customer continues to use the rtd assay and insturments and has provided the results of their external quality assessment (ukneqas) showing proficiency and passing results.(b)(4).

• Type of Device: BENCHMARK XT
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• MDR Report Key: 6590004
• MDR Text Key: 75918374
• Report Number: 2028492-2017-00001
• Device Sequence Number: 1
• Product Code: MYA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 05265231001
• Device Catalogue Number: 750-700
• Other Device ID Number: UDI 04015630981069
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: 04/24/2017
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1