Company Gets a Guilty Reading in Glucose Monitor Case

FDA Consumer, March, 2001 by Michelle Meadows

A device designed to assure diabetes patients they could "be sure at every step" when measuring their blood glucose (sugar) levels turned out to be defective, giving false readings that landed some patients in the hospital.

LifeScan Inc., a Johnson & Johnson subsidiary in Milpitas, Calif., marketed its SureStep blood glucose monitoring system to people with diabetes who had difficulty performing daily blood tests, such as patients with shaky hands or visual impairments. But the SureStep system had two major problems that LifeScan failed to reveal to customers and to report, as required, to the Food and Drug Administration.

The first problem was that the meter sometimes displayed an Error 1 (ER1) message instead of showing a "HI" reading when a patient's blood glucose level exceeded the highest number the system could handle--500 milligrams per deciliter (mg/dl). LifeScan didn't reveal what this ER1 message could mean, even when customers called to complain about it. The second problem was that the meter sometimes produced inaccurate low readings when a test strip was not fully inserted into the meter. Meter instructions stated that the strip should be inserted properly, but didn't indicate that failing to do so could produce inaccurate low results.

According to Jud Bohrer, special agent in charge of FDA's Office of Criminal Investigations (OCI) in Los Angeles, "LifeScan not only failed to advise customers of these design defects, but the medical device reports they did file contained false, incomplete or misleading information because of nondisclosure of either problem as required by law."

LifeScan learned its SureStep system was defective in 1993, but applied to FDA for clearance to market the product in 1994, without reporting any problems. Based on the company's reports, FDA cleared the application in 1995, and LifeScan marketed SureStep in Canada, Japan, and the United States from 1996 to 1997. The company didn't tell consumers about the product's defects until at least late 1997, and didn't inform FDA until 1998. In a recent press statement, LifeScan apologized for its mistakes and said that no one at the company intentionally sought to mislead consumers or the government.

Around February 1997, the company filed an application for clearance to market another device called the SureStep Pro Hospital Meter. This product also produced false low results if test strips were improperly inserted, but LifeScan failed to mention that in its application, according to David W. Bourne, the resident agent in charge in the San Francisco office of FDA's OCI. The SureStep Pro was similar to the SureStep, but had an added feature of being able to store up to 6,000 glucose readings. Still unaware of any defects in the SureStep system, FDA cleared the SureStep Pro for marketing in May 1997.

Two internal whistleblowers came forward later in 1997, a move that kicked off a three-year investigation of LifeScan by government agencies, including FDA's OCI, the U.S. Department of Justice, and the U.S. Attorney's Office for the Northern District of California. It wasn't until June 1998--after the OCI began its investigation--that LifeScan instituted a voluntary recall of all SureStep meters made before July 27, 1997.

On Dec. 15, 2000, LifeScan pleaded guilty to misdemeanor charges and agreed to pay $60 million in criminal and civil fines, according to court documents filed in the U.S. District Court in San Jose, Calif. The company admitted that SureStep's labeling was deficient, that the company failed to file medical device reports when it should have, and that reports it did file contained false or misleading information because they didn't disclose problems with the SureStep system.

From 1996 to 1998, LifeScan received more than 2,000 complaints of inaccurate low readings, some because of incomplete strip insertion, and more than 700 complaints about "ER1" messages, some thai should have been "HI" readings. At least 61 of the error messages were associated with illness or injury, including some hospitalizations. LifeScan corrected these problems in 1997 and 1998, and says that its current SureStep products that remain on the market are not affected by the recent legal settlement.

As part of its three-year probation, LifeScan has to provide written procedures for handling medical device reporting and customer complaints to FDA's Center for Devices and Radiological Health (CDRH). And when customers call, LifeScan representatives will have to ask questions from a script that CDRH approves. LifeScan will also have to conduct a new study to determine whether the SureStep and SureStep Pro meters meet FDA's requirements, and present its results to CDRH for re,view before April 2001.