Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Sweating (2444)
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Event Date 11/14/2020 |
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 kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 their adc freestyle libre 2 sensor did not alarm when glucose was low.The customer was asleep when his wife noticed that he was sweating and provided him with juice and sugar.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) was 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 was performed on the sensor plug assembly, no failure modes were observed.The returned sensor was successfully activated with a known good reader.Linearity test was performed and the low glucose alarm was successfully activated.No malfunction or product deficiency was identified all pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported their adc freestyle libre 2 sensor did not alarm when glucose was low.The customer was asleep when his wife noticed that he was sweating and provided him with juice and sugar.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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