MAUDE Adverse Event Report: GENEID

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Breast Cancer (1759)

Event Date 03/17/2014

Event Type  Other  

Event Description

Patient's genetic test was a false negative.Shortly after this first test the patient was diagnosed with breast cancer, she was retested through another laboratory ((b)(6)) and we found that she is, in fact, a brca1 mutation carrier.This incident was reported to clia.

• Brand Name: GENEID
• Type of Device: GENEID
• MDR Report Key: 5535575
• MDR Text Key: 41524969
• Report Number: MW5061341
• Device Sequence Number: 1
• Product Code: OQS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR