Model Number 71992-01 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Cognitive Changes (2551)
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Event Date 07/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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 "replace sensor" message and was unable to obtain readings.As a result, customer experienced "memory loss" and self-treated with "food" prior to having contact with a healthcare professional (hcp).The hcp provided third-party treatment of intravenous glucose "drops" (type/dose unspecified).There was no report of death or permanent impairment associated with this event.
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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 "replace sensor" message and was unable to obtain readings.As a result, customer experienced "memory loss" and self-treated with "food" prior to having contact with a healthcare professional (hcp).The hcp provided third-party treatment of intravenous glucose "drops" (type/dose unspecified).There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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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.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 and poise voltage 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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