MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC; HER2 DUAL ISH

Model Number 780-4422

Device Problem False Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 03/12/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation of the customer run reports indicate that correct staining, using the same product (inform her2 dual ish dna probe cocktail), lot d11446 was observed on slides run simultaneously as the suspect slides.

Event Description

Customer alleges ventana's assay produced a false positive result resulting in herceptin treatment.

• Type of Device: HER2 DUAL ISH
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC; 1910 e innovation park drive; 1910 e innovation park drive; tucson AZ 85755 1962
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS, INC; 1910 e innovation park dr; none; tucson AZ 85755
• Manufacturer Contact: tim giblin ; 1910 e innovation park dr; na; tuscon, AZ 85755 ; 5208777035
• MDR Report Key: 5369068
• MDR Text Key: 36031330
• Report Number: 2028492-2016-00001
• Device Sequence Number: 1
• Product Code: NYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 780-4422
• Device Catalogue Number: 05586640001
• Device Lot Number: D11446
• Other Device ID Number: UDI #04015630970155
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• 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
• Patient Outcome(s): Other