Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 03/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time, product has not yet 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 kit 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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An error message was reported with the adc device.A caller reported a ¿replace sensor¿ error was received on the same day of applying the sensor.As a result, the customer was unable to obtain sensor scans and the customer became hypoglycemic and experienced a fall, and lost consciousness.The customer was unable to self-treat and the mother provided dextrose as treatment and then the customer self-treated with food.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the sensor and was observed the sensor plug was glued to the sensor which is use related issue.Therefore, issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the adc device.A caller reported a ¿replace sensor¿ error was received on the same day of applying the sensor.As a result, the customer was unable to obtain sensor scans and the customer became hypoglycemic and experienced a fall, and lost consciousness.The customer was unable to self-treat and the mother provided dextrose as treatment and then the customer self-treated with food.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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