Model Number 71953-01 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problems
Hypoglycemia (1912); Convulsion/Seizure (4406)
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Event Date 07/13/2022 |
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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A complaint was received reporting touch screen issues while using the adc device.As a result, the customer experienced unspecified hypoglycemic symptoms and had a seizure.The customer had contact with a healthcare professional and provided an unspecified infusion for diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
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Event Description
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A complaint was received reporting touch screen issues while using the adc device.As a result, the customer experienced unspecified hypoglycemic symptoms and had a seizure.The customer had contact with a healthcare professional and provided an unspecified infusion for diagnosis of hypoglycemia.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.Dhrs 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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Search Alerts/Recalls
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