Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Diabetic Ketoacidosis (2364); Convulsion/Seizure (4406)
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Event Date 07/15/2023 |
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 record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit 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 "scan error" sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced seizure and reported being able to self-treat with unspecified medication.In addition, customer had contact with a healthcare professional who provided unspecified treatment for the diagnosis of diabetic ketoacidosis.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 fully seated and no issues were observed.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Extracted data from the returned sensor using approved software.Sensor found to be in state 6 (indicating early termination).Attempted communication between returned sensor and known good reader.Reader successfully communicated with the returned sensor.Scan timeout error message was not observed.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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A customer reported a "scan error" sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced seizure and reported being able to self-treat with unspecified medication.In addition, customer had contact with a healthcare professional who provided unspecified treatment for the diagnosis of diabetic ketoacidosis.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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