An error message was reported with the abbott diabetes care (adc) device.The customer received an error-14 message on their reader display and was unable to obtain readings.As a result, the customer experienced symptom described as "trembling and without strength", requiring treatment of insulin (type/dose unknown) administered by a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.
|
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.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 it has been determined that there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.Clinical data was reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and precision strips 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 submitted.All pertinent information available to abbott diabetes care has been submitted.
|
The reported reader has been returned and investigated with retained test strips.Visual inspection has been performed on the returned reader and no issues were observed.Control solution testing has been performed and all results were within range specification.No error message was observed.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.If the partial 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.
|
An error message was reported with the abbott diabetes care (adc) device.The customer received an error-14 message on their reader display and was unable to obtain readings.As a result, the customer experienced symptom described as "trembling and without strength", requiring treatment of insulin (type/dose unknown) administered by a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.
|