The abbott specialist performed technical investigations, revealed the issue was a configuration error performed by the abbott specialist that led to a hiv workflow and sample management.A review of 12 months of complaint data did not identify any adverse trends or any non-statistical trends or any atypical complaint activity associated with this described issue.A review of tracking and trending of the aliniq found no additional complaints replated to the complaint issue.Therefore, no trends were identified.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of the labeling addresses the customer¿s issue: aliniq ams configurator user manual en 3.01 rev0 provides adequate information about how to configure the test type in aliniq ams and the validation method in the analyzer section.Based on the information within the complaint, a malfunction was identified: a human (abbott specialist) error in the aliniq ams configuration was the cause of the reported issue which caused a failure in the device to perform as intended at the customer site.No deficiencies were identified in the aliniq ams middleware.
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