Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 11/05/2021 |
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 freestyle libre sensor kit were reviewed and the dhrs showed freestyle libre sensor kit 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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A customer reported that the freestyle libre sensor detached prematurely on the fourth day of wear and was unable to obtain scan readings.The customer became hypoglycemic, experiencing a fall and loss of consciousness, and required the treatment of "table salt" provided by doctor at the hospital.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor patch, no physical damage was observed.No issues were observed with the adhesive.An extended investigation for this complaint was previously completed and reported in the previous submission, therefore no further investigative actions are required.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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A customer reported that the freestyle libre sensor detached prematurely on the fourth day of wear and was unable to obtain scan readings.The customer became hypoglycemic, experiencing a fall and loss of consciousness, and required the treatment of "table salt" provided by doctor at the hospital.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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