Model Number 71992-01 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 06/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested for investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in section 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 person reported on behalf of customer who encountered an unspecified issue in which on "(b)(6) 2022, they applied a sensor that only lasted until (b)(6) 2022." it was further reported that the customer experienced a loss of consciousness and was treated with glucose by spouse.Please note that customer indicated applying a device that was allegedly expired.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 been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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, the case will be re-opened, and a physical investigation will be performed.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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Event Description
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A person reported on behalf of customer who encountered an unspecified issue in which on "(b)(6).2022, they applied a sensor that only lasted until (b)(6).2022." it was further reported that the customer experienced a loss of consciousness and was treated with glucose by spouse.Please note that customer indicated applying a device that was allegedly expired.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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