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This article was originally published in The Gray Sheet

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Executive Summary

Firm's Model 508 insulin infusion pumps distributed between Oct. 4 and Nov. 18, 1999 could have "a rare and minor software error" that could lead to a patient receiving an incorrect dosage, the firm announced Nov. 19. Notification containing programming instructions has been sent to all users who purchased the pump during the relevant time period and new systems contain an upgraded version of the software. FDA has been notified but no adverse event reports have been filed, according to the company

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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