Model Number 71953-01 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problems
Hypoglycemia (1912); Diaphoresis (2452); Convulsion/Seizure (4406)
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Event Date 07/29/2022 |
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 device mfg date 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 that their adc device display froze and the entire screen was white.The customer further reported experiencing sweating and a seizure and was unable to self-treat.The customer had contact with a health care professional who provided unspecified treatment for the diagnosis of hypoglycemia.No further information was provided.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 that their adc device display froze and the entire screen was white.The customer further reported experiencing sweating and a seizure and was unable to self-treat.The customer had contact with a health care professional who provided unspecified treatment for the diagnosis of hypoglycemia.No further information was provided.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 reader 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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Search Alerts/Recalls
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