Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Chills (2191); Diaphoresis (2452)
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Event Date 06/16/2022 |
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 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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Event Description
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A customer reported via webform that the adc device detached prematurely on the 3rd day of insertion.As a result, the customer experienced symptoms of sweating, chills, and clammy skin and received treatment of insulin/glucagon and/or other medication by a third party.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Extracted data from returned sensor using approved software.Sensor was found to be in state 5 (indicating normal termination).The sensor plug was properly seated in the mount.Removed the sensor plug and inspected the plug assembly, no failure modes were observed.Sensor was reprogrammed and sim vivo (simulation of the electrical signal produced by the sensor tail) test was performed and all results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported via webform that the adc device detached prematurely on the 3rd day of insertion.As a result, the customer experienced symptoms of sweating, chills, and clammy skin and received treatment of insulin/glucagon and/or other medication by a third party.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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