Model Number 71940-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/13/2021 |
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 sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 receiving a ¿sensor is not functioning¿ error message on the same day of applying the adc freestyle libre sensor.The customer experienced blurred eyes and was unable to self-treat, requiring a shot in the eye from a healthcare professional.No further information was provided as the customer refused to continue troubleshooting.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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