Patient identifier: (b)(6).Section a patient information: no further patient information was provided.The complaint investigation included a review of the complaint text, complaint activity trending data and labeling associated with the magnesium assay.Although a return sample was available it was not necessary for the investigation.Review of the complaint text indicated that the sample was retested at the customer site on the same instrument, and on another instrument with similar lower normal results.Additionally, qc results were reported to be within range.A review of tickets determined that there is normal complaint activity for reagent lot#: 72837un20.Tracking and trending reports were reviewed and no trends were identified.Historical performance of reagent lot#: 72837un20 was evaluated using world-wide field data from.The patient data was analyzed, and compared to an established control limit.This evaluation indicated that the patient median result for lot#: 72837un20 is within the established control limits.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue, or deficiency was identified for the magnesium reagent, lot#: 72837un20.
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