COBAS 6000 C (501) MODULE C501

[83307249] (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[83307250] The customer received questionable results for trigl triglycerides, chol2 cholesterol gen. 2, and ldl_c ldl-cholesterol plus 3rd generation. Of the data provided, only the results for triglycerides and cholesterol were discrepant. The initial triglyceride result was 427 mg/dl and the repeat result was 150 mg/dl. The repeat result on another analyzer was 149 mg/dl. The initial cholesterol result was 329 mg/dl and the repeat result was 230 mg/dl. The repeat result on another analyzer was 215 mg/dl. None of the erroneous results were reported outside the laboratory. There was no allegation of an adverse event. The triglyceride reagent lot number was 22259201 with an expiration date of 02/28/2018. The cholesterol reagent lot number was 18399500 with an expiration date of 10/31/2017. The service personnel found the metal plate had scratched the edge of the cuvettes and generated a white powder that contaminated the cuvettes as they rotated. He adjusted the position of the metal plate and performed precision testing. The provided calibration and qc data was acceptable and ruled out general reagent issues. It was noted the calibrator had expired prior to its use. The investigation could not determine a specific root cause. The issue appeared to be related to a customer handling issue due to the use of the expired calibrator material, insufficient maintenance actions, and improper centrifugation conditions.
Patient Sequence No: 1, Text Type: D, B5