MAUDE Adverse Event Report: DIADEXUS, LLC PLAC

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

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Results from the test vary greatly from lab to lab making it hard for my doctor to tell if i am at risk or not.

• Brand Name: PLAC
• Type of Device: PLAC
• Manufacturer (Section D): DIADEXUS, LLC
• MDR Report Key: 4540913
• MDR Text Key: 5543922
• Report Number: MW5040842
• Device Sequence Number: 1
• Product Code: NOE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2015

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?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2015
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 82