Model Number 71992-01 |
Device Problems
Device Alarm System (1012); No Audible Alarm (1019)
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Patient Problems
Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 01/31/2023 |
Event Type
Injury
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Event Description
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An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness and seizure.The customer reported unspecified treatment from third-party due to this issue.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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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 is the date abbott diabetes care became aware of the event.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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An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness and seizure.The customer reported unspecified treatment from third-party due to this issue.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre sensors, 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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