A "check sensor" error message was reported with the adc device and the customer was unable to obtain readings.As a result, the customer experienced a loss of consciousness and dizziness however, was able to self-treat with insulin (dose/type unspecified).There was no third party medical intervention reported as no further information was provided.There was no report of death or permanent impairment associated with this event.
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The customers product has been requested for investigation.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered in section h4 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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