Model Number 71992-01 |
Device Problem
No Device Output (1435)
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Patient Problem
Hypoglycemia (1912)
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Event Date 07/25/2022 |
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 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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A caller reported that while trying to scan with freestyle librelink application, the adc device sensor would not be detected.As a result, the customer was unable to self-treat and was treated with oral sugar by a non-health care professional.No further information was provided.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.
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Event Description
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A caller reported that while trying to scan with freestyle librelink application, the adc device sensor would not be detected.As a result, the customer was unable to self-treat and was treated with oral sugar by a non-health care professional.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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