Model Number 71992-01 |
Device Problem
Failure to Fire (2610)
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Patient Problems
Dehydration (1807); Hyperglycemia (1905); Dizziness (2194)
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Event Date 08/07/2023 |
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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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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Customer reported attempting to apply an adc device and being unsuccessful due to the inserter not firing, and as a result of being unable to monitor glucose levels, experiencing thirstiness and dizziness and was unable to self-treat.The customer had contact with a healthcare professional (hcp) and received hcp administration of insulin via injection for treatment of hyperglycemia diagnosis.There was no report of death or permanent impairment associated with this event.Ith 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 sensor kits were reviewed and the dhrs showed the 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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Event Description
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Customer reported attempting to apply an adc device and being unsuccessful due to the inserter not firing, and as a result of being unable to monitor glucose levels, experiencing thirstiness and dizziness and was unable to self-treat.The customer had contact with a healthcare professional (hcp) and received hcp administration of insulin via injection for treatment of hyperglycemia diagnosis.There was no report of death or permanent impairment associated with this event.Ith this event.
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Search Alerts/Recalls
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