Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Tachycardia (2095); Loss of consciousness (2418)
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Event Date 11/29/2023 |
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 in section h4 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 adc device detached prematurely and was unable to obtain sensor readings.The customer experienced palpitation and a loss of consciousness.The customer had contact with a healthcare professional who administered a glucagon injection and glucose via orally and intravenously for the diagnosis of hyperglycemia.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 the adc device detached prematurely and was unable to obtain sensor readings.The customer experienced palpitation and a loss of consciousness.The customer had contact with a healthcare professional who administered a glucagon injection and glucose via orally and intravenously for the diagnosis of hyperglycemia.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for libre sensor kits were reviewed and the dhrs showed libre sensor kits 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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