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FDA Enforcement Report

http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.html






PRODUCT

Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall # Z-1007-2007

CODE

All serial numbers for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722

RECALLING FIRM/MANUFACTURER

Medtronic MiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing.

REASON

Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemia.

VOLUME OF PRODUCT IN COMMERCE

334,000 pumps

DISTRIBUTION

Nationwide and Internationally







PRODUCT

Ascensia Contour Blood Glucose Monitoring System (Bayer) Diabetes Care System; Product 7152A, Recall # Z-1001-2007

CODE

Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010

RECALLING FIRM/MANUFACTURER

Bayer Healthcare LLC, Mishawaka, IN, by telephone on June 6, 2007 and by e-mail on June 12, 2007. Firm initiated recall is ongoing.

REASON

Incorrect Unit of Measure displayed: The meters report results in the wrong unit of measurement for Canadian users.

VOLUME OF PRODUCT IN COMMERCE

16 units

DISTRIBUTION

Canada