Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Dehydration (1807); Vomiting (2144); Diabetic Ketoacidosis (2364)
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Event Date 03/13/2023 |
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.Customer indicated event occurred "summer of 2022".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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A customer reported a low readings issue with the adc device.The customer reported unspecified lower sensor readings, while experiencing symptoms of vomiting, dehydration, and shortness of breath.The customer had contact with a healthcare provider where they were diagnosed with diabetic ketoacidosis.The customer was placed on iv insulin, potassium, and glucose for treatment, and hospitalized for 2 and 1/2 days.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any 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.
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Event Description
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A customer reported a low readings issue with the adc device.The customer reported unspecified lower sensor readings, while experiencing symptoms of vomiting, dehydration, and shortness of breath.The customer had contact with a healthcare provider where they were diagnosed with diabetic ketoacidosis.The customer was placed on iv insulin, potassium, and glucose for treatment, and hospitalized for 2 and 1/2 days.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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