Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problem
No Information (3190)
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Event Date 10/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg 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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Event Description
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Customer received a message 'lo' (reading <2.2 mmol/l) on the freestyle libre 2 sensor compared to a blood glucose reading of 9.4 mmol/l obtained on an unspecified device and having contact with an hcp who advised removal of the sensor.Customer further reported receiving unspecified third-party treatment, however no further information was provided and attempts to gather additional information have been unsuccessful thus far.There was no report of death or permanent impairment associated with this event.
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Event Description
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Customer received a message 'lo' (reading <2.2 mmol/l) on the freestyle libre 2 sensor compared to a blood glucose reading of 9.4 mmol/l obtained on an unspecified device and having contact with an hcp who advised removal of the sensor.Customer further reported receiving unspecified third-party treatment, however no further information was provided and attempts to gather additional information have been unsuccessful thus far.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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No product has been returned and a valid serial number has not been provided.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.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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