Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
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Event Date 05/13/2023 |
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 webform complaint was received in which it was reported a customer received a "replace sensor" message on the adc device and was unable to obtain readings.As a result, customer experienced a loss of consciousness and was treated by an hcp with glucogel for the diagnosis of dka.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.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.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A webform complaint was received in which it was reported a customer received a "replace sensor" message on the adc device and was unable to obtain readings.As a result, customer experienced a loss of consciousness and was treated by an hcp with glucogel for the diagnosis of dka.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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