Model Number 71940-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
Loss of consciousness (2418)
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Event Date 08/31/2023 |
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.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 bent inserter needle with the adc device.Due to this issue, the customer did not have a working sensor to monitor glucose and experienced a loss of consciousness and was able to self-treat with food when they regained consciousness.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.This also serves as a correction report.Section e1 (country) was incorrectly updated in the initial report.Correction has been made.
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Event Description
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A customer reported a bent inserter needle with the adc device.Due to this issue, the customer did not have a working sensor to monitor glucose and experienced a loss of consciousness and was able to self-treat with food when they regained consciousness.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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