The most probable root causes associated with this failure mode are disconnected, faulty or damaged components 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.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.Sensor kit expiration date is 30-apr-2022.The medical event associated with this case occurred on 28-mar-2024 which confirms the usage of the device beyond the useful life of the device.No additional investigation are required as the device met its specification lifespan.No additional investigations are required as the sensor was expired at the time of use, and the device met its specification lifespan.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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.A follow-up report will be submitted if any additional information is obtained.
|
An adhesive issue was reported with the abbott diabetes care (adc) device.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, the customer experienced dizziness, sweatiness, vomiting, and felt very hot.A blood glucose level of 20 mg/dl was obtained from an unspecified device and the customer was provided sugar water and a glucagon injection by a non-healthcare provider for treatment.The customer went to the hospital where the customer's basal insulin dose was adjusted but no treatment was provided.There was no report of death or permanent impairment associated with this event.
|