BLOOD SMEAR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for BLOOD SMEAR manufactured by Theranos.

Event Text Entries

[38752043] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5060284
• MDR Report Key: 5447818
• Date Received: 2016-02-16
• Date of Report: 2016-02-16
• Date of Event: 2016-02-15
• Date Added to Maude: 2016-02-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BLOOD SMEAR
• Generic Name: BLOOD SMEAR
• Product Code: MXJ
• Date Received: 2016-02-16
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THERANOS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-02-16