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

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2021

Event Type  Injury  

Event Description

Discovered in late (b)(6) 2021 that the roche ventana ultra stainer reported a false negative value.False report impacted patient's treatment plan.Treatment plan updated due to false negative report.Fda safety report id# (b)(4).

• Brand Name: ROCHE VENTANA ULTRA STAINER
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.
• MDR Report Key: 12751193
• MDR Text Key: 280475154
• Report Number: MW5105125
• 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?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female