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 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.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.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 date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing 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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A customer reported via social media complaint, a high reading issue with the freestyle libre 2 sensor.The customer reported obtaining sensor readings of 149 mg/dl and 155 mg/dl and feeling dizzy, loss of balance, and unable to walk straight and obtaining a capillary result of 47 mg/dl on an unspecified meter, a few minutes later.The customer was provided with milkshakes for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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