Model Number 71992-01 |
Device Problem
No Device Output (1435)
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Patient Problems
Fall (1848); Loss of consciousness (2418)
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Event Date 02/01/2023 |
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 date the incident occurred is unknown.The date entered in section date of event is the date abbott diabetes care became aware of the event.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 via social media an unspecified issue with the adc device.The customer wrote that they lost consciousness and fell, and that the sensor "never worked at all".No further details were provided and customer has not responded to requests for further details.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.A tripped trend review was conducted for the reported complaint and fs libre sensor , 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 customer reported via social media an unspecified issue with the adc device.The customer wrote that they lost consciousness and fell, and that the sensor "never worked at all".No further details were provided and customer has not responded to requests for further details.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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