Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Nausea (1970); Hot Flashes/Flushes (2153); Convulsion/Seizure (4406)
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Event Date 01/21/2022 |
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 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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Event Description
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A customer reported a "replace sensor" message with the freestyle libre 2 sensor, and was therefore unable to monitor glucose via scan readings.The customer subsequently developed symptoms described as mood disorder, panic attacks, hot flashes, circulatory problems, nausea, and experienced a seizure.The customer had contact with a healthcare professional, who treated customer with oral glucose.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported a "replace sensor" message with the freestyle libre 2 sensor, and was therefore unable to monitor glucose via scan readings.The customer subsequently developed symptoms described as mood disorder, panic attacks, hot flashes, circulatory problems, nausea, and experienced a seizure.The customer had contact with a healthcare professional, who treated customer with oral glucose.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has 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.All pertinent information available to abbott diabetes care has been submitted.Upon extended investigation, it was determined that the serial number provided by the customer (3mh008ng8wq) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
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Search Alerts/Recalls
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