Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Headache (1880); Hypoglycemia (1912); Chills (2191); Loss of consciousness (2418)
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Event Date 07/09/2021 |
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.Dhrs (device history record) 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 a "replace sensor" message from the freestyle libre 2 sensor rendering her unable to obtain glucose readings.The customer became hypoglycemic, experiencing headache, "cold body", and loss of consciousness.Customer was unable to self-treat due to her symptoms and required the treatment of cola provided by her son.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported a "replace sensor" message from the freestyle libre 2 sensor rendering her unable to obtain glucose readings.The customer became hypoglycemic, experiencing headache, "cold body", and loss of consciousness.Customer was unable to self-treat due to her symptoms and required the treatment of cola provided by her son.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor 3mh005kp40h 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, the 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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