Abbot diabetes care product quality engineering (pqe) investigated the alarm-2 (signal loss alarm) complaint.The serial number of the freestyle libre 2 sensor associated with this complaint is unknown.During investigation of the track and trend review related to alarm-2 cases in april 2020, this failure mode was identified and is a known manufacturing issue that impacts libre 2 sensors manufactured at flex buffalo grove (fbg).As the serial number of the sensor associated with this complaint is unknown, pqe is unable to determine if the sensor is impacted by this manufacturing issue.Outside of the known manufacturing issue, the available tripped trend reports for libre 2 sensor and alarm-2 have been reviewed.The review did not identify any additional trends that would indicate a product related issue related to this complaint.If the product is returned, the case will be re-opened, and a physical investigation will be performed.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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The customer¿s caregiver reported the customer received a display message of "signal loss" on the adc freestyle libre 2 sensor thus did not receive any alarm alerts when blood glucose was low.It was further reported the customer was under-sugared and experienced symptoms of ¿cold sweat, dizziness, and nausea¿ and was unable to self-treat.The customer had contact with a healthcare professional and was diagnosed with hypoglycemia and was administered glucose injection.The hcp gave the customer ¿metrosorim¿ and humalog and also reduced the customer¿s lantus (insulin) from 80 units to 58 units.No further details were provided.There was no report of death or permanent impairment associated with this event.
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