Model Number 71953-01 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problems
Hot Flashes/Flushes (2153); Convulsion/Seizure (4406)
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Event Date 10/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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The requested product has been returned and investigation is in process.A follow-up report will be submitted once additional information is obtained.The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 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 frozen screen was reported with the adc device, and the customer was unable to obtain readings.The customer experienced feeling "hot, cold," and a seizure and an unspecified self- treatment was received.There was no report of death or permanent impairment 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.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 frozen screen was reported with the adc device, and the customer was unable to obtain readings.The customer experienced feeling "hot, cold," and a seizure and an unspecified self- treatment was received.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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