(b)(6) 2019, a (b)(6) patient visited the facility due to abdomen pain.The patient's serum specimen was collected at 15:20 and tested on the alere hcg combo cassette.A positive result was obtained at the 5 minute read time.No treatment was provided based on false positive result.The same serum specimen was retested on the beckman access 2 and a confirmatory hcg quant of 8 miu/ml was obtained.(b)(6) 2019: an additional confirmatory quant test was performed on the beckman access 2 and a result of 9 miu/ml was obtained.Patient diagnosis was updated to adrenal insufficiency.No adverse patient outcomes were reported.Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi)-no deviations noted.
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