Model Number 71992-01 |
Device Problem
Low Readings (2460)
|
Patient Problem
Hyperglycemia (1905)
|
Event Date 12/22/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A caller reported that the customer had a low readings issue with the freestyle libre 2 sensor.The caller reported unspecified low readings, and the customer self-treated with food.As the customer did not have test strips, she had contact with a healthcare professional.A healthcare meter reading of 150 mg/dl was obtained, as compared to a sensor scan of 80 mg/dl.The healthcare professional replaced the sensor and gave the customer an insulin injection (dose/type unknown).There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.The issue is therefore not confirmed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A caller reported that the customer had a low readings issue with the freestyle libre 2 sensor.The caller reported unspecified low readings, and the customer self-treated with food.As the customer did not have test strips, she had contact with a healthcare professional.A healthcare meter reading of 150 mg/dl was obtained, as compared to a sensor scan of 80 mg/dl.The healthcare professional replaced the sensor and gave the customer an insulin injection (dose/type unknown).There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
No product has been returned.Extended investigation has been performed for the reported complaint.And there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed, and the dhrs showed the fs libre sensor and 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.
|
|
Event Description
|
A caller reported, that the customer had a low readings issue with the freestyle libre 2 sensor.The caller reported, unspecified low readings.And the customer self-treated with food.As the customer did not have test strips.She had contact with a healthcare professional.A healthcare meter reading of 150 mg/dl was obtained, as compared to a sensor scan of 80 mg/dl.The healthcare professional replaced the sensor.And gave the customer an insulin injection (dose/type unknown).There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|