Lingo Glucose System

Description of Event or Problem

An adverse skin reaction was reported during wear of the Abbott Diabetes Care (ADC) device. The customer experienced symptoms described as bruising at the sensor site following application of the ADC device and self-treated with topical Polysporin cream to the affected area. There was no report of death or permanent impairment associated with this event.

Additional Manufacturer Narrative

The product has been requested back for investigation and the customer agreed to return the device; however, at this time product has not yet been received. An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The Device History Records (DHRs) for the product were reviewed and the DHRs showed the Lingo Glucose Biosensor passed all tests prior to release.Dose Audit Reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for Lingo Glucose Biosensor. Environmental Monitoring Reports were reviewed, including Bioburden and Endotoxin testing, and demonstrated that all monitoring processes continue to meet ADC minimum requirements for product quality. 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.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.