Johnson & Johnson, the world’s biggest maker of health-care products, said it was recalling almost 1.9 million glucose meters in the wake of a death of a patient in Europe following an inaccurate blood-sugar reading.
The company’s LifeScan unit is recalling the blood glucose meters, including 90,000 that were sold in the U.S., because they shut off or provide inaccurate readings at extremely high blood-sugar levels. The recall affects three models, including one sold in the U.S. called OneTouch VerioIQ, said David Detmers, a company spokesman.
J&J started to investigate the issue late last year when the problem was noticed by internal company testing, he said. Soon after that, a report was received of a European patient who died following an inaccurate, low reading on the OneTouch VerioPro, one of the now-recalled meters. J&J hasn’t been able to determine whether the faulty reading led to the death, Detmers said. No adverse events have been reported in the U.S.
“The products are not performing as intended at these high blood-glucose levels,” Detmers said yesterday in a phone interview. “We place patient safety first and want to make sure we remove the products and replace them.”
J&J has recalled a variety of products since 2010 including over-the-counter medicines such as children’s Tylenol, metal hip implants and a bone putty used to stop bleeding. The medicine recalls forced New Brunswick, New Jersey-based J&J to close a factory and sign a consent decree with U.S. regulators to oversee some manufacturing. The company also faces more than 1,800 lawsuits from women who blame internal injuries on vaginal mesh implants and 10,000 lawsuits from patients who say they got faulty hip replacements.
The errors with the blood-sugar meters, which occur at super-high levels of 1,024 milligrams per deciliter and higher, are caused by a software problem, Detmers said. It took time investigate and understand the scope of the software malfunction after reports of trouble with the product, he said.
Such extremely high blood-sugar levels rarely occur, but when they do “it is a serious health risk requiring immediate medical attention,” J&J said in a statement yesterday announcing the recall. Faulty readings in this circumstance may lead to serious health problems or death, the company said.
The meters affected by the recall are the OneTouch VerioIQ, the OneTouch VerioPro, and the OneTouch VerioPro+, Detmers said. Patients can continue using the VerioIQ meter until the product is replaced, he said. The VerioIQ shuts down at the ultra high level, which may be a sign of extreme hyperglycemia requiring a patient get immediate medical attention, J&J said in its statement.
Sales of the Verio systems are “very modest,” said Ernie Knewitz, a J&J spokesman, who declined to provide further details. LifeScan generated $2.6 billion in 2012 sales of diabetes care products, J&J reported in a regulatory filing.