Five things we found in the FDA’s hidden device

Quote:

---

1. Blood glucose meters for patients with diabetes had more unique incidents than any other device in the database, logging 2.4 million reports over the past 20 years.

Almost all the products were made by LifeScan, which had been a Johnson & Johnson company until it was sold to a private equity firm in 2018. Common problems included displaying incorrect messages, losing power or being damaged before customers started using them, according to the database.

"When you're trying to manage a chronic disease, and especially if your numbers are dangerously high, that's life-threatening," said Linda Radach, who chairs the medical device committee for the Patient Safety Action Network.

LifeScan did not return requests for comment.

The FDA said the number of glucose meter problems in the alternative summary reporting database shouldn't be a surprise.

---