MAUDE Adverse Event Report: ILLUMINA INC. ILLUMINA TEST KIT; CONDUCTANCE REGULATOR GENE, VARIANT. GENE, SEQUENCE DETECTION

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/05/2017

Event Type  Injury  

Event Description

Received genetic report from illumina sequencing assay which incorrectly identified health disorders impacting genetic counseling guidance.

• Brand Name: ILLUMINA TEST KIT
• Type of Device: CONDUCTANCE REGULATOR GENE, VARIANT. GENE, SEQUENCE DETECTION
• Manufacturer (Section D): ILLUMINA INC.
• MDR Report Key: 6800095
• MDR Text Key: 83036558
• Report Number: MW5071604
• Device Sequence Number: 1
• Product Code: NPQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR