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 02/02/2022 |
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 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.The date of event 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 caller reported the error message while a customer was scanning the adc freestyle libre 2 sensor.As a result, the customer had a fall and had a loss of consciousness and provided dextrose and a ¿fanta¿ for treatment.No further details regarding the medical event were provided.There was no report of death or permanent injury associated with this event.
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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 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.The date of event 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 caller reported the error message while a customer was scanning the adc freestyle libre 2 sensor.As a result, the customer had a fall and had a loss of consciousness and provided dextrose and a (b)(6) for treatment.No further details regarding the medical event were 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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