Model Number 71953-01 |
Device Problem
Data Problem (3196)
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Patient Problems
Dizziness (2194); Malaise (2359)
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Event Date 11/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 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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Event Description
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A missing or incorrect data in memory issue was reported with the adc device.A customer reported missing data from the sensor and experienced symptoms described as ¿not feeling well, couldn't see that clearly, and dizziness.The customer was seen at a hospital and was provided unspecified medical treatment for the reported issue.No further treatment was reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and fs libre readers, and there were no adverse trends that indicate any potential product related issues.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.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.This report serves as a correction for mfg report 2954323-2022-43246 as the section h10 has been updated.
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Event Description
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A missing or incorrect data in memory issue was reported with the adc device.A customer reported missing data from the sensor and experienced symptoms described as ¿not feeling well, couldn't see that clearly, and dizziness.The customer was seen at a hospital and was provided unspecified medical treatment for the reported issue.No further treatment was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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