Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Hot Flashes/Flushes (2153); Diaphoresis (2452); Shaking/Tremors (2515); Convulsion/Seizure (4406)
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Event Date 01/02/2022 |
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 record) 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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A customer reported a "replace sensor" message with the freestyle libre 2 sensor on the 1st day of wear, after accidently knocking sensor site into door-frame.The customer was therefore unable to obtain sensor readings, and developed symptoms of sweating, feeling hot, shaking, irritation, blurred vision, and seizure.However, the customer reported being able to self-treat with milk, juice, and cookies.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 is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.No malfunction or product deficiency was identified.Therefore issue is not confirmed.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 "replace sensor" message with the freestyle libre 2 sensor on the 1st day of wear, after accidently knocking sensor site into door-frame.The customer was therefore unable to obtain sensor readings, and developed symptoms of sweating, feeling hot, shaking, irritation, blurred vision, and seizure.However, the customer reported being able to self-treat with milk, juice, and cookies.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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