Model Number 71940-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Nausea (1970); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 03/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date 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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Event Description
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A customer reported a bent sensor tip with the adc device.As a result, customer experienced symptoms described as nausea, seizure, a loss of consciousness and was unable to self-treat.Customer received treatment from a third-party and a healthcare professional (ambulance/hospital) who provided unspecified dose of unspecified injection.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported a bent sensor tip with the adc device.As a result, customer experienced symptoms described as nausea, seizure, a loss of consciousness and was unable to self-treat.Customer received treatment from a third-party and a healthcare professional (ambulance/hospital) who provided unspecified dose of unspecified injection.No further information was provided.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 on the reported complaint and it has been determined that there was no indication that the product did not meet specifications.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensor and there were no adverse trends that indicate any product-related issues.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.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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Search Alerts/Recalls
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