Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hyperglycemia (1905); Blurred Vision (2137); Dizziness (2194)
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Event Date 11/24/2023 |
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 in section h4 is the date abbott diabetes care became aware of the event.This report concerns a unites states customer who indicated that the adverse event occurred while in bahamas.Please note that the reported device is not on market in bahamas.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An adhesive issue was reported with the adc sensor.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, customer experienced blurry vision, light headedness and was unable to self-treat, requiring third-party administration of insulin injection from a healthcare professional for a diagnosis of hyperglycemia.There was no report of death or permanent impairment 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 ((b)(6)) and previously reported to the fda was not a valid serial number. therefore, section d4 was updated to unk.
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Event Description
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An adhesive issue was reported with the adc sensor.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, customer experienced blurry vision, light headedness and was unable to self-treat, requiring third-party administration of insulin injection from a healthcare professional for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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