Theranos Inc.’s lab in Arizona failed to ensure some patients who got potentially inaccurate diabetes test results were notified, according to a federal inspection report obtained through a public-records request.
The embattled Silicon Valley company also performed patient blood-coagulation tests on a machine its staff configured improperly, according to the report and the company’s response to regulators.
Theranos additionally failed to verify that devices’ precision or accuracy were in line with their manufacturer’s instructions for tests such as those for blood-glucose, pregnancy and triglycerides, a key part of cholesterol panels, according to a report from the September 2016 inspection.
Theranos closed the Scottsdale, Ariz., lab in October, about a week after the inspectors visited the facility, citing a plan to refocus the company on developing its own machines to sell to lab operators. It said then it was exiting the business of doing patient blood tests itself altogether. The findings show that Theranos repeatedly violated its own policies and procedures, as well as a manufacturer’s instructions for using lab-testing equipment.
How wearable technology can transform health care
Around 12-15 million people use wearable technology for health care – a market that includes Fitbit, Apple, Samsung and LG. MarketWatch spoke to Kate McCarthy, a health-care analyst that manages a rare disease using an Apple Watch and a service dog.
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