MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. VENTANA ULTRA STAINER; SLIDE STAINER, AUTOMATED

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

False negative result received.Pathologist quickly identified false negative result produced by device.No impact to patient's treatment plan.Fda safety report id# (b)(4).

• Brand Name: VENTANA ULTRA STAINER
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.
• MDR Report Key: 12751461
• MDR Text Key: 280516750
• Report Number: MW5105130
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female