Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 10/20/2022 |
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 low reading issue with the adc device.The customer received unspecified low reading on sensor and experienced a lightheadedness, couldn't stand up, and lost consciousness.A reading of 46 mg/dl from an hcp meter and customer was treated with glucose iv by paramedics and was also given crackers and sugar drinks when they regained consciousness.There was no report of death or permanent impairment associated with this event.
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Event Description
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A customer reported a low reading issue with the adc device.The customer received unspecified low reading on sensor and experienced a lightheadedness, couldn't stand up, and lost consciousness.A reading of 46 mg/dl from an hcp meter and customer was treated with glucose iv by paramedics and was also given crackers and sugar drinks when they regained consciousness.There was no report of death or permanent impairment 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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Search Alerts/Recalls
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