Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problems
Fatigue (1849); Hemorrhage/Bleeding (1888); Hypoglycemia (1912); Shaking/Tremors (2515)
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Event Date 03/09/2023 |
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 caller reported a high readings issue with the adc device.The caller reported received an unspecified high sensor readings when compared to a built in meter.The customer reported bleeding and experienced tiredness, shaking, couldn't get up and was unable to self-treat, requiring treatment of orange juice by spouse.No further treatment was reported.There was no report of death or permanent impairment 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 caller reported a high readings issue with the adc device.The caller reported received an unspecified high sensor readings when compared to a built in meter.The customer reported bleeding and experienced tiredness, shaking, couldn't get up and was unable to self-treat, requiring treatment of orange juice by spouse.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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