Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Discomfort (2330)
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Event Date 06/20/2023 |
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 mfg date is unknown.The date entered in section h4 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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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after five days of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced "felt very bad/not good/not well" and was unable to self-treat, requiring third-party treatment of glucagon (dose unspecified) by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Event Description
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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after five days of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced "felt very bad/not good/not well" and was unable to self-treat, requiring third-party treatment of glucagon (dose unspecified) by a non-healthcare professional.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 not yet been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhr(device history review) for the libre sensor kits were reviewed and the dhrs showed the libre sensor kits passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.
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Search Alerts/Recalls
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