An error message was reported with the adc device.The caregiver reported an "error code 3" message with the reader and was unable to obtain blood glucose results.The customer was vomiting, shaking, feeling cold, pale, shivering and became "a bit aggressive".The customer was treated with glucogel provided by caregiver.It was also reported the paramedics were called but no further details were provided.There was no report of death or permanent impairment associated with this event.
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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 and a valid serial number has not been provided.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.A tripped trend review was conducted for the reported complaint and fs libre reader and no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow up report will be submitted.All pertinent information available to abbott diabetes care has been submitted.
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An error message was reported with the adc device.The caregiver reported an "error code 3" message with the reader and was unable to obtain blood glucose results.The customer was vomiting, shaking, feeling cold, pale, shivering and became "a bit aggressive".The customer was treated with glucogel provided by caregiver.It was also reported the paramedics were called but no further details were provided.There was no report of death or permanent impairment associated with this event.
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