Investigation conclusion: retention products were tested with hcg quality control cut-off standard (25 miu/ml) and high level hcg clinical urine (212.6 iu/ml, 215.2 i u/ml, 203.5 iu/ml).All devices showed positive results at read time and met quality control release specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Case details do not indicate if the urine sample was a first morning catch.Per the package insert, very dilute urine may not contain representative levels of hcg.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
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The patient's last menstrual period was (b)(6) 2018.On (b)(6) 2018, a urine sample was collected and a hcg one step pregnancy test device produced a negative hcg result (urinalysis: glu -ve, ket 15, sg 1.025, blo trace, lysed, pro trace, nit -ve, leu -ve, ph 5.5).On (b)(6) 2018, the patient was prepped for a possible appendectomy.A beta hcg quantitative blood test was performed and produced a result of 219 miu/ml with a progesterone of 31 (no units provided).No procedure was performed based on the positive beta hcg quantitative result.On (b)(6) 2018, a repeat beta hcg quantitative blood test was performed and produced a result of 498 miu/ml with a progesterone of 32 (no units provided).The pregnancy was determined to be viable and the patient was later discharged with an outpatient gynae referral.
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