Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Hemorrhage/Bleeding (1888); Neuropathy (1983); Dizziness (2194); Discomfort (2330)
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Event Date 06/13/2023 |
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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A bleeding issue was reported after insertion of the abbott diabetes care (adc) device.As a result, customer experienced "sick with dizziness", "fatigue", difficulty breathing", "electric shock", "headache", "uncomfortable", and was unable to self-treat, requiring third-party treatment of "fed and insulin administered" 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 been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.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 bleeding issue was reported after insertion of the abbott diabetes care (adc) device.As a result, customer experienced "sick with dizziness", "fatigue", difficulty breathing", "electric shock", "headache", "uncomfortable", and was unable to self-treat, requiring third-party treatment of "fed and insulin administered" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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