Model Number 71940-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/21/2021 |
Event Type
Injury
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Event Description
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Customer reported experiencing a "frozen shoulder" while wearing a freestyle libre sensor and having contact with an hcp who performed an x-ray of the arm and provided an unspecified injection for treatment.There was no report of death or permanent impairment 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 there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and 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.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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Search Alerts/Recalls
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