Model Number 71953-01 |
Device Problem
Battery Problem (2885)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 12/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time product has not yet 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 conducted for the reported complaint and fs libre reader and no trends were identified that would indicate any product related issues.The available tripped trend reports were reviewed for charging cable and ac adapter and 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 battery/power issue with the adc device.The customer reported that the "reader does not work" and was unable to use device to monitor glucose.The customer experienced a loss of consciousness and was treated with glucagon administered by family member.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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At this time product has not yet 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 conducted for the reported complaint and fs libre reader and 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.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 customer reported a battery/power issue with the adc device.The customer reported that the "reader does not work" and was unable to use device to monitor glucose.The customer experienced a loss of consciousness and was treated with glucagon administered by family member.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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