MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. CONFIRM ANTI-ER (SP1) PRIMARY ANTIBODY; ESTROGEN RECEPTOR PRIMARY ANTIBODY

Model Number 05278414001

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Breast Neoplasm (2438); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2013

Event Type  Injury  

Event Description

Laboratory customer reported an allegation of a false negative diagnostic result with the use of our estrogen receptor (er) tissue diagnostic assay.The original test was conducted in (b)(6) 2013 and resulted in a negative er diagnosis.The pt required a recession in (b)(6) 2014 and testing at that time indicated a positive er diagnosis.

Manufacturer Narrative

The customer has discarded the implicated kit.Labeling, including troubleshooting and precautions, continues to be correct.The kit was used in other pt cases and reportedly performed as claimed.There is no feedback from the customer as to confirmatory tests they may have performed on the pt in (b)(6), or in regard to current status of the pt.

• Brand Name: CONFIRM ANTI-ER (SP1) PRIMARY ANTIBODY
• Type of Device: ESTROGEN RECEPTOR PRIMARY ANTIBODY
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.; 1910 east innovation park dr.; tucson AZ 85755
• Manufacturer Contact: 1910 east innovation park dr.; tucson, AZ 85755 ; 5208777239
• MDR Report Key: 3733075
• MDR Text Key: 4326758
• Report Number: 2028492-2014-00001
• Device Sequence Number: 1
• Product Code: MYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2014
• Device Model Number: 05278414001
• Device Catalogue Number: 790-4325
• Device Lot Number: C08379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other