Model Number 71953-01 |
Device Problem
Data Problem (3196)
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Patient Problems
Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 01/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned as reporter indicated the device was discarded.Physical investigation of product is not anticipated.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.The date of event is unknown.The date entered in section date of event 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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Customer reported "missing memory" while using the adc device.Customer further reported experiencing a loss consciousness and/or a seizure.No further information was provided as the customer refused to share additional information.There was no report of death or permanent injury associated with this event.
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Event Description
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Customer reported "missing memory" while using the adc device.Customer further reported experiencing a loss consciousness and/or a seizure.No further information was provided as the customer refused to share additional information.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 libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.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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Search Alerts/Recalls
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