Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Dizziness (2194); Shaking/Tremors (2515)
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Event Date 11/28/2022 |
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 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 a "replace sensor" error message with the adc device and was unable to obtain readings.As a result, customer experienced dizzy, shaky and was unable to self-treat.Customer had contact with a healthcare professional who obtained a laboratory result of 57 mg/dl, adjusted unspecified medication, and provided 2 glucose tablets as treatment for the diagnosis of hypoglycemia.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.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.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and 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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A customer reported a "replace sensor" error message with the adc device and was unable to obtain readings.As a result, customer experienced dizzy, shaky and was unable to self-treat.Customer had contact with a healthcare professional who obtained a laboratory result of 57 mg/dl, adjusted unspecified medication, and provided 2 glucose tablets as treatment for the diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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