Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
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Event Date 07/29/2021 |
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 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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Customer reported receiving a "replace sensor" message on the day of applying the adc freestyle libre 2 sensor.Customer experienced tremors, confusion and a loss of consciousness due to low blood sugar.Customer was seen at the hospital due to perform a x-ray as she had "a fracture in shoulder" due to a fall.There was no report of death or permanent injury associated with this event.
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Event Description
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Customer reported receiving a "replace sensor" message on the day of applying the adc freestyle libre 2 sensor.Customer experienced tremors, confusion and a loss of consciousness due to low blood sugar.Customer was seen at the hospital due to perform a x-ray as she had "a fracture in shoulder" due to a fall.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor 3mh0065u6g0 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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Search Alerts/Recalls
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