At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.An attempt was made to replicate the user complaint and high/low glucose alarms were successfully received on an iphone device with ios 15.1.1/fsll version 2.5.3.3088 using a known good libre 2 sensor.No issues were identified with the librelink app.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered in date of event 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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An alarming issue was reported with the adc device.A customer reported that the sensor alarm failed to trigger when their glucose was high.As a result, the customer experienced symptoms of feeling sick, thirsty, tiredness, high heart rate, and a loss of consciousness.The customer was treated with glucose, iv infusion, and insulin shot (type/dose unknown) by a non-healthcare professional.There was no further information was provided.There was no report of death or permanent injury associated with this event.
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