Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Blurred Vision (2137); Hot Flashes/Flushes (2153)
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Event Date 08/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing 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 the low glucose alarm failed to trigger from the adc device.The customer felt hypoglycemic with symptoms of blurred vision, flushness, and loss of consciousness.The customer was seen by a healthcare professional who administered glucose via iv for treatment.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 the low glucose alarm failed to trigger from the adc device.The customer felt hypoglycemic with symptoms of blurred vision, flushness, and loss of consciousness.The customer was seen by a healthcare professional who administered glucose via iv for treatment.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 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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