Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Hyperglycemia (1905); Nausea (1970); Pain (1994)
|
Event Date 12/26/2023 |
Event Type
Injury
|
Event Description
|
A "replace sensor" error message was reported with the adc device and the customer was unable to obtain readings.As a result, the customer experienced leg pain, muscle pain, nausea and heaviness and was unable to self-treat, requiring third-party administration of insulin (type/dose unknown), water, and/or tea from a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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.
|
|
Manufacturer Narrative
|
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 and cracked sensor neck was observed.The cause of the cracked sensor neck is likely attributed to shipment of the used sensor back to adc for investigation.Sensor state 5 is an indication of normal sensor termination, therefore the cracked sensor neck observed during investigation occurred post-wear.In addition, the passing of all tests during the investigation indicates that the cracked sensor neck did not impact the sensor's ability to still generate an accurate glucose reading.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.This issue is therefore not confirmed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A "replace sensor" error message was reported with the adc device and the customer was unable to obtain readings.As a result, the customer experienced leg pain, muscle pain, nausea and heaviness and was unable to self-treat, requiring third-party administration of insulin (type/dose unknown), water, and/or tea from a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|
|