Model Number 71953-01 |
Device Problem
Power Problem (3010)
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Patient Problems
Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 04/18/2021 |
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 the freestyle libre 2 reader would only power on while connected to the data cable.Customer experienced symptoms described as sweating and hand tremors and was unable to self-treat, requiring treatment of juice and "3 guts".There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The reported reader was returned and investigated.Performed visual inspection on the returned reader and no issues were observed.The reader powered on with a button press.Therefore, the issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported the freestyle libre 2 reader would only power on while connected to the data cable.Customer experienced symptoms described as sweating and hand tremors and was unable to self-treat, requiring treatment of juice and "3 guts".There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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