Model Number 71953-01 |
Device Problem
Power Problem (3010)
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Patient Problem
Loss of consciousness (2418)
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Event Date 07/16/2022 |
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 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 being unable to test using the adc device due to a fast draining battery.As a result, the customer experienced a loss of consciousness.There was no report of third-party intervention or contact with a healthcare professional.No further treatment was required.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported being unable to test using the adc device due to a fast draining battery.As a result, the customer experienced a loss of consciousness.There was no report of third-party intervention or contact with a healthcare professional.No further treatment was required.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.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.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release and correct cable and adapter was part of the kit pack.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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Search Alerts/Recalls
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