The product has been requested back for an 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 there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and freestyle 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 in section b3 is the date abbott diabetes care became aware of the event.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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A low readings issue was reported, through social media, with use of the abbott diabetes care (adc) device.Customer received lower sensor scan result of 40 mg/dl when compared to readings of 80 mg/dl obtained on unspecified device.As a result, customer experienced "ketosis" and had to go to the hospital where they received unspecified third-party treatment by a healthcare professional (hcp).There was no report of death or permanent impairment associated with this event.
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