MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. ANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML; PAN CK

Model Number 760-2135

Device Problem False Negative Result (1225)

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

Event Date 11/17/2014

Event Type  Injury  

Event Description

Patient tissue tested at clinic was initially reported as negative, however, upon consult with another facility tissue reported positive.

Manufacturer Narrative

Requests for additional information and discussions with pathologist at clinic are ongoing.No reports of impact to patient care at this time.

• Brand Name: ANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML
• Type of Device: PAN CK
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: tim giblin ; 1910 east innovation park dr.; tucson, AZ 85755 ; 5208777035
• MDR Report Key: 4584984
• MDR Text Key: 16180429
• Report Number: 2028492-2015-00001
• Device Sequence Number: 1
• Product Code: NJT
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2015

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: Health Professional
• Device Model Number: 760-2135
• Device Catalogue Number: 05266840001
• Other Device ID Number: 04015630971572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/06/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR