Model Number 71992-01 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
Hyperglycemia (1905); Dizziness (2194); Discomfort (2330)
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Event Date 07/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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Sensor (b)(6) has been returned.Extended investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or additional information is obtained.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the abbott diabetes care (adc) device.Customer received a "sensor ended" message and was unable to obtain readings.As a result, customer experienced "weakness, dizziness, inability to walk", and was unable to self-treat, requiring contact with a healthcare professional (hcp).The hcp performed a blood glucose measurement, with unspecified results, prior to providing third-party treatment of "saline" for a diagnosis of hyperglycemia.There was no report of death or permanent impairment 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) and poise voltage testing were performed and all results were within specification.No malfunction or product deficiency was identified.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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the abbott diabetes care (adc) device.Customer received a "sensor ended" message and was unable to obtain readings.As a result, customer experienced "weakness, dizziness, inability to walk", and was unable to self-treat, requiring contact with a healthcare professional (hcp).The hcp performed a blood glucose measurement, with unspecified results, prior to providing third-party treatment of "saline" for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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