Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problem
No Information (3190)
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Event Date 11/07/2020 |
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 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 low readings issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported receiving unspecified low sensor scans from (b)(6) 2020 through (b)(6) 2020 and consequently experienced tingling in his leg.The ambulance was called and a blood glucose reading of 11.9 mmol/l was obtained on the hcp meter and the customer received unspecified treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A low readings issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported receiving unspecified low sensor scans from (b)(6) 2020 through (b)(6) 2020 and consequently experienced tingling in his leg.The ambulance was called and a blood glucose reading of 11.9 mmol/l was obtained on the hcp meter and the customer received unspecified treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.
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Search Alerts/Recalls
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