H6: investigation summary: customer reported sensor adhesion defect and a false positive result.Two out of three photos received showed a sensor adhesion defect.Bd was unable to duplicate customer¿s experience with the bactec product.Retention samples were visually inspected with satisfactory results.Batch/sensor history records were reviewed, and all testing were within specification for product release.Blood background was performed with satisfactory results.A complaint history review was conducted and batch has been previously investigated for the reported defect.No additional testing is required at this time.Sensor adhesion scrape test is performed to each sensor batch as part of release criteria.Complaint is confirmed based on photos received.The vision system is challenged prior each lot.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.Corrective actions preventive actions (capa) 2882676 was initiated to further investigate these types of complaints and determine any appropriate actions to reduce their occurrence.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
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