Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Cognitive Changes (2551); Convulsion/Seizure (4406)
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Event Date 05/19/2023 |
Event Type
Injury
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Event Description
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An alarm issue was reported with the adc device.Customer did not receive low glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced "memory disorder", convulsions, and a loss of consciousness, requiring treatment of nasal glucagon by their mother.Customer reported regaining consciousness and was later seen by at hospital and gives doliprane for headaches and a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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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 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 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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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed on sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating early termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The low glucose threshold in the alarm settings was set to 100 mg/dl.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarm was successfully activated.Therefore , this 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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An alarm issue was reported with the adc device.Customer did not receive low glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced "memory disorder", convulsions, and a loss of consciousness, requiring treatment of nasal glucagon by their mother.Customer reported regaining consciousness and was later seen by at hospital and gives doliprane for headaches and a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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