Model Number 71940-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Fatigue (1849); Hyperglycemia (1905); Dizziness (2194); Polydipsia (2604)
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Event Date 06/22/2022 |
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 the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.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 an error message with the adc device.The customer was therefore unable to obtain sensor readings and became dizzy, fatigued, and thirsty.The customer was unable to self-treat, requiring treatment of insulin (dose/type unknown) by a third-party.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 an error message with the adc device.The customer was therefore unable to obtain sensor readings and became dizzy, fatigued, and thirsty.The customer was unable to self-treat, requiring treatment of insulin (dose/type unknown) by a third-party.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 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 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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Search Alerts/Recalls
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