Complete patient identifier: (b)(6).All available patient information has been included.No additional patient details are available.This event is being filed on an international product, list 02k91-39, which has a similar us product, list 2k91-33.This event is also being filed under manufacturer report number 3002809144-2019-01072, for a second suspect medical device.An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of the historical performance of the likely cause lots, a review of the device history record, and a review of product labeling.Review of the ticket trending and lot search did not identify an increase in complaint activity related to the complaint issue.The historical performance of reagent lots 03010m800 and 03037m800 was evaluated using world wide data.This evaluation indicated that the patient median result for lots 03010m800 and 03037m800 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lots 03010m800 and 03037m800.A review of the device history record was performed on lots 03010m800 and 03037m800, which did not show any related potential non-conformances, deviations, or non-conformances.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.
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