A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced symptoms reported as feeling sick and having headaches.As a result, the customer was unable to self-treat and presented to the local hospital.Upon arrival, the customer was administered saline and insulin intravenously (2) for treatment for hyperglycemia diagnosis.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
|
A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced symptoms reported as feeling sick and having headaches.As a result, the customer was unable to self-treat and presented to the local hospital.Upon arrival, the customer was administered saline and insulin intravenously (2) for treatment for hyperglycemia diagnosis.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
|
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.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.
|