FDA Warns Abbott Diabetes Care About Manufacturing Practices of Its Glucose Meters

Disclosures

July 21, 2010

July 21, 2010 — Abbott Diabetes Care has received a warning letter from the US Food and Drug Administration (FDA) about how it manufactures its FreeStyle glucose meters.

The meters include the FreeStyle Navigator Continuous Glucose Monitoring System, currently unavailable in the United States as a result of what the company calls a "supply interruption."

In a July 2 letter, the FDA faulted Abbott Diabetes Care, a unit of Abbott, with violations of quality-control requirements, including how it followed up on the discovery of empty blister packs and scratches on glucose-meter test strips.

The FDA also stated that the company lacked enough qualified personnel to ensure that manufacturing processes met agency standards. The job description for the director of quality systems, for example, required this employee to have a bachelor's degree in a scientific, engineering, or technical discipline. The person in this position instead had a business administration degree, according to the agency.

The warning letter stemmed from an FDA inspection of the company's facilities in Alameda, California, earlier this year.

In a press release, Abbott Diabetes Care said it "has taken and continues to take the actions necessary to address the items outlined in the letter and is communicating those actions directly to the agency."

Warning Letter Comes On Top of Other Agency Actions

The warning letter, posted Tuesday on the agency's Web site, is the latest in a series of FDA actions involving glucose meters from Abbott Diabetes Care. In August 2009, the agency announced that patients with diabetes who receive therapeutic products containing certain sugars other than glucose could experience serious, although rare, injuries if their glucose meters used test strips that incorporated the GDH-PQQ enzyme. Such test strips will react with nonglucose sugars such as maltose to produce a falsely high glucose reading, which might cause patients with diabetes to take too much insulin. The FDA identified Abbott Diabetes Care as one of several glucose meter manufacturers that relied on GDH-PQQ test strips.

Since then, the company has won FDA clearance for new test strips based on another enzyme that is not affected by maltose and other common nonglucose sugars. Abbott spokesperson Gregory Miley told Medscape Medical News that the new test strips would hit the US marketplace later this year.

In May, the FDA also announced a class 2 recall of the FreeStyle Navigator Continuous Glucose Monitoring System because of the possibility of cracks in the device's plastic housing near the battery compartment, which could allow moisture to enter and trigger device failure or inaccurate readings. Mr. Miley said that the company had alerted both its customers and the FDA about this problem in April 2009.

In April 2010, Abbott Diabetes Care disclosed that it was experiencing a "supply interruption" with the FreeStyle Navigator system and therefore was unable to provide patients with replacement receivers and transmitters, or sell the complete system to new customers. Mr. Miley told Medscape Medical News that the company had resumed selling the product in 6 European countries and Israel.

"We're working as quickly as we can on it for the United States," he said.

Mr. Miley declined to say what caused the supply interruption.

The full text of the warning letter to Abbott Diabetes Care about its manufacturing processes for glucose meters is available on the agency's Web site.

To report adverse events related to these devices, contact MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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