Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Chills (2191); Dizziness (2194); Convulsion/Seizure (4406)
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Event Date 04/24/2021 |
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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and 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 alarm issue was reported with the freestyle libre 2 sensor.Customer reported receiving a sensor scan result of 2.5mmol/l but indicated the low glucose alarm did not sound.As a result, the customer experienced symptoms described as sensation of cold, powerless, dizziness, and a seizure.Customer called paramedics and upon their arrival, customer was treated with intravenous glucose.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.Data was extracted using approved software and the sensor was in state 5 (indicating normal termination).Visual inspection was performed on the returned sensor plug and no failure modes were observed.The sensor was activated with known good reader, linearity test was performed, and the low glucose alarm was successfully activated.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 alarm issue was reported with the freestyle libre 2 sensor.Customer reported receiving a sensor scan result of 2.5mmol/l but indicated the low glucose alarm did not sound.As a result, the customer experienced symptoms described as sensation of cold, powerless, dizziness, and a seizure.Customer called paramedics and upon their arrival, customer was treated with intravenous glucose.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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