A Diagnostics & Imaging Week

A Johnson & Johnson (New Brunswick, New Jersey) unit failed to properly investigate and report complaints about certain devices used by diabetics to measure blood sugar, the FDA charged in a letter made public last week.

The FDA said it uncovered that problem and other violations of quality-control requirements during an inspection of a LifeScan (Milpitas, California) facility from April through June.

In a letter to the company, the FDA said LifeScan did not properly review and investigate complaints that the OneTouch Ultra blood glucose meters may have been providing incorrect measurements.

The company also did not meet requirements for reporting potentially serious injuries that may have been related to the devices within 30 days, the FDA letter said.

“You should take prompt actions to correct these deviations,” the Dec. 7 letter said.

The letter said LifeScan had taken some steps to correct the problems, but other proposed fixes had not been completed.

In April, LifeScan alerted consumers it was possible for users of OneTouch Ultra, InDuo and OneTouch FastTake Meters to accidentally change the unit of measurement and misinterpret results (Diagnostics & Imaging Week, April 21, 2005).