Model Number 71953-01 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problems
Hypoglycemia (1912); Discomfort (2330); Loss of consciousness (2418)
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Event Date 05/04/2023 |
Event Type
Injury
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Event Description
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A battery/power issue was reported with the abbott diabetes care (adc) device.Customer reported being unable to test due to a fast draining battery.As a result, customer experienced a loss of consciousness, "felt bad", and was able to self-treat with "pieces of sugar." there was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The product has been requested back for an investigation.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 device history review (dhrs) for the libre 2 reader were reviewed and the dhrs showed the libre 2 reader 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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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and no issues were observed.Visual inspection was performed on the usb/charging cable and no issues were observed.Usb/charging cable has passed the testing.Reader was de-cased.Visual inspection has been performed and no issues were observed.A power consumption test was performed and the results were within the specification range.Therefore, issue is not confirmed due to fast draining battery not observed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A battery/power issue was reported with the abbott diabetes care (adc) device.Customer reported being unable to test due to a fast draining battery.As a result, customer experienced a loss of consciousness, "felt bad", and was able to self-treat with "pieces of sugar." there was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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