LINGO GLUCOSE SYSTEM

Description of Event or Problem

A customer reports an "explosion" of their Abbott Diabetes Care device, 30 minutes after opening the package., There was no report of fire, smoke, or electric shock. There was no report of death, serious injury, or mistreatment associated with this event.

Additional Manufacturer Narrative

The product has been requested back for an investigation and the customer agreed to return the device; however, at this time product has not yet been received.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.A valid serial number has not been provided. An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification. A Tripped Trend review was conducted for the reported complaint and the product; no trends were identified that would indicate any product related issues.If product is returned, a physical investigation will be performed per ADC's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to Abbott Diabetes Care has been submitted.