Model Number 71953-01 |
Device Problem
Battery Problem (2885)
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Patient Problems
Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)
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Event Date 11/13/2021 |
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 reader were reviewed and the dhrs showed the libre 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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Event Description
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Customer reported being unable to test using his adc freestyle libre 2 reader due to the reader being dropped and not turning on with button press.Customer experienced dizziness, sweating, blurred vision and required treatment of coca-cola provided by a third party.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated.Visually inspected the reader and no issues were observed.Reader's button was not damaged.Reader did not turn on with button, strip, or usb cable insertion.Unable to extract the data from reader due to bnp-1 issue.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported being unable to test using his adc freestyle libre 2 reader due to the reader being dropped and not turning on with button press.Customer experienced dizziness, sweating, blurred vision and required treatment of coca-cola provided by a third party.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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