Reporter is making this complaint on behalf of his wife.He alleges the sensor was placed on his wife's arm and the material separated causing the sensor to fall off.Reporter·believes the device is defective and very concerned about the numbers the sensor reads.His wife relies on the sensor for her insulin intake and he believes sensor was reading inaccurate numbers and hence the wrong treatment of insulin administered to his wife.He alleges his wife suffered two heart attacks and the doctors were not able to tell him how the heart attacks happened but he believes it stems from the faulty sensors that was producing inaccurate results.He reported to manufacturer who replaced the defective device.Reporter is still concerned and advises he has notified (b)(6) not to pay for the device, and he has stopped using the device for his wife.He wants the fda to look into the safety of this device as he is really concerned about the device.His wife has previously used the todays sensor and they worked fine but the manufacturer doesn't make those anymore.Reporter advised the defective sensor looks like it had "exploded" causing the materials to separate and fall off.He thinks the device if not investigated and recalled can cause harm to patients who use these devices.
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