Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problem
Hypoglycemia (1912)
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Event Date 12/22/2021 |
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 in 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 high reading issue with the freestyle libre 2 sensor.The customer reported experiencing symptom of "buzzing in the ears", with a sensor scan reading of 320 mg/dl as compared to a built-in meter result of 37 mg/dl (using expired test strips).The customer reported requiring treatment of orange juice and dark chocolate by a third-party.No further treatment was required.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.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.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 high reading issue with the freestyle libre 2 sensor.The customer reported experiencing symptom of "buzzing in the ears", with a sensor scan reading of 320 mg/dl as compared to a built-in meter result of 37 mg/dl (using expired test strips).The customer reported requiring treatment of orange juice and dark chocolate by a third-party.No further treatment was required.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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