Model Number 71702-01 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Vertigo (2134)
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Event Date 09/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The date of manufacture is unknown.The date listed is the date when 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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Customer reported his adc freestyle libre sensor produced error messages for more than 2 hours, after seven days of wear.He further reported that on (b)(6) 2018 he became ¿dizzy¿ and "confused" but could not receive a scan result.Customer¿s wife administered a glucagon injection.No additional treatment was reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Visual inspection has been performed on the returned sensor patch and no issues were observed.Sensor plug was properly seated.Removed plug and inspected plug assembly.No failure mode was observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (normal termination).Sensor inserted into the sim-vivo test fixture.All results were within specification.No product deficiency was identified.
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Event Description
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Customer reported his adc freestyle libre sensor produced error messages for more than 2 hours, after seven days of wear.He further reported that on (b)(6) 2018 he became ¿dizzy¿ and "confused" but could not receive a scan result.Customer¿s wife administered a glucagon injection.No additional treatment was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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