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

Patient had a false negative result reported by the roche ventana ultra stainer.Issue identified by pathologist.False negative result did not impact patient 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: 12751391
• MDR Text Key: 280517029
• Report Number: MW5105129
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female