Model Number 71953-01 |
Device Problem
Power Problem (3010)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 05/08/2023 |
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 manufacturing 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 battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to device working, but was not charging.As a result, the customer experienced hypoglycemia and loss of consciousness and was unable to self-treat, requiring treatment of coca to drink and administration of glucagon injection provided by third-party.There was no report of death or permanent impairment 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 the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to device working, but was not charging.As a result, the customer experienced hypoglycemia and loss of consciousness and was unable to self-treat, requiring treatment of coca to drink and administration of glucagon injection provided by third-party.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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