Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 10/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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At this time product has not yet been returned.An 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 kit was reviewed and the dhrs showed the fs libre 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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An adhesive issue was reported with the freestyle libre 2 sensor.The sensor prematurely detached after 5 days of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced cramping, a seizure, and loss of consciousness and had contact with an hcp who performed magnetic resonance imaging (mri), electrocardiography (ekg) testing, and obtained a laboratory blood glucose result of 35 mg/dl.Customer was administered intravenous glucose and fluids for treatment of hypoglycemia.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor 3mh006yvm78 has been returned and investigated.No physical damage was observed on the returned sensor patch and no issues were observed with the returned sensor adhesive.No malfunction or product deficiency has been identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An adhesive issue was reported with the freestyle libre 2 sensor.The sensor prematurely detached after 5 days of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced cramping, a seizure, and loss of consciousness and had contact with an hcp who performed magnetic resonance imaging (mri), electrocardiography (ekg) testing, and obtained a laboratory blood glucose result of 35 mg/dl.Customer was administered intravenous glucose and fluids for treatment of hypoglycemia.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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