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Cara feiler
3 years ago
Agency labeled the recall as Class 2, meaning there is a reasonable risk of serious adverse events or a remote risk of serious events. An inaccurate bolus screen issue has prompted a recall of nearly 2,000 MiniMed 640G insulin pumps in ten European countries. According to a recall notice posted on the U.S. Food and Drug […]
Agency labeled the recall as Class 2, meaning there is a reasonable risk of serious adverse events or a remote risk of serious events. An inaccurate bolus screen issue has prompted a recall of nearly 2,000 MiniMed 640G insulin pumps in ten European countries. According to a recall notice posted on the U.S. Food and Drug Administration’s (FDA’s) website, there may be situations where “the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.” The agency labeled the recall as Class 2, meaning there is a reasonable risk of serious adverse events or a remote risk of serious events.
Medtronic sent a letter to customers on June 19th informing them of the inaccurate bolus screen issue. The company instructed customers to not activate bolus insulin delivery based on a blood glucose value older than 12 minutes.
The pump was distributed to Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom. Medtronic plans to submit the device for PMA submission in the United States later this year, according to Fierce Medical Devices.
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