MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC; CONFIRM ER

Model Number 05278406001

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

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

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

It is unknown if there is a deterioration in patient health.We have asked the customer multiple times with no response.Investigation statement and conclusion: there is no indication of a malfunction of ventana medical system's instrument or assay.No corrections taken by the manufacturer since no ventana product malfunction identified.However information was provided to the customer on the "impact of environmental stress on various histology slide types".The customer has now changed from histobond slides to another slide manufacturer (tomo slides from matsunami).They have reported no issues since switching slide types.This is an initial and final report.

Event Description

Customer used a same slide positive control tissue section which stained positive.Patient sample was negative and accordingly patient was diagnosed triple negative (er, pr, her2).Six weeks later, the patient sample was re-stained in another hospital and found to be er-positive.They assumed the reason for the failed staining in the first run was the slide surface properties on the slides they used.The customer has now changed from histobond slides to another slide manufacturer (tomo slides from matsunami).

• Type of Device: CONFIRM ER
• 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; none; tucson AZ 85755 1962
• Manufacturer Contact: tim giblin ; 1910 east innovation park dr; na; tucson, AZ 85755 ; 5208777035
• MDR Report Key: 6592947
• MDR Text Key: 76014193
• Report Number: 2028492-2017-00002
• Device Sequence Number: 1
• Product Code: NQN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140465
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 05278406001
• Device Catalogue Number: 790-4324
• Device Lot Number: ASKU
• Other Device ID Number: UDI #04015630972241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• 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