Model Number 71992-01 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/14/2022 |
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 date of event is unknown.The date entered is based on the report of "2 weeks ago".The device mfg 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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Caller reported that as a result of a defective adc sensor, customer "became very ill" for days and received unspecified care in a clinic.No further details were 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 for the reported complaint and it has been determined that there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and fs libre 2 sensors, and a trend was investigated where a probable root cause was related to an insertion issue.However without a valid sensor number or product return, the root cause of the particular issue associated with this complaint is unknown and cannot be further determined.Clinical data was reviewed and confirmed that freestyle libre 2 sensors continue to be safe, effective, and perform as intended in the field.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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Caller reported that as a result of a defective adc sensor, customer "became very ill" for days and received unspecified care in a clinic.No further details were provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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