MAUDE Adverse Event Report: THERANOS BLOOD SMEAR

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 02/15/2016

Event Type  malfunction  

Event Description

I had a manual blood smear at (b)(6).The first report came back with poikilocytosis 1+, polychromasia 1+, ovalocytes 1+, tear drop cells 1+, spherocyte 1+, manual diff with smear performed at: (b)(6).Then discontinued the test, assured me the results were accurate, and then finally retested me.The second report came back with hypochromasia.I feel they're either ignorant or unethical.They shouldn't be giving smear results that are suspect and assure me that they're correct.I asked specifically is this a transport artifact and they said any lab results were accurate.That's the annoying part and the only reason for the report.No lab test is perfect, but when a blood smear takes almost a week to come back and it comes back with bizarre results with no comment or pathology sign off that was not seen on any previous manual smear and i ask if it's likely an artifact, they should be careful in what they say.

• Brand Name: BLOOD SMEAR
• Type of Device: BLOOD SMEAR
• Manufacturer (Section D): THERANOS
• MDR Report Key: 5447818
• MDR Text Key: 38752043
• Report Number: MW5060284
• Device Sequence Number: 1
• Product Code: MXJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 88