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 and stability were 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 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.All pertinent information available to abbott diabetes care has been submitted.
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Abbott diabetes care received a user report from danish medicines agency (dkma) which reported the following information: a healthcare professional (hcp) reported on behalf of the customer¿s mother who reported that the adc device was receiving the same low readings of 2.9 mmol/l, 3.0 mmol/l, and 3.3 mmol/l.The customer was taken to a hospital where they were hospitalized and a glucose result of 24 mmol/l was obtained and the customer was diagnosed with hyperglycemia.The hcp attempted to remove the sensor and it was discovered that the sensor tip was bent and did not penetrate the skin.No further information was reported.There was no report of death or permanent injury associated with this event.
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