Investigation conclusion: retention products were tested with hcg quality control cut-off standard (20 miu/ml) and high level hcg clinical urine (212.6 iu/ml, 215.2 iu/ml, 221.9 iu/ml).All devices showed positive results at read time and met quality control specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The reported complaint could not be replicated in-house with retention products.Case details indicate the hcg concentration of the sample was 9 (no units provided).Per the package insert this test has a sensitivity of 20 miu/ml.False negatives may occur when the levels of hcg are below the sensitivity level of the test.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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On (b)(6) 2018, the patient arrived at the facility for birth control counseling and a request to start depo-provera.At 12:12 pm a urine sample was collected and produced a negative hcg result using a fisher-sure-vue hcg-stat serum/urine test.The depo-provera injection was administered based on the fisher-sure-vue hcg-stat serum/urine result.At 4:06 pm, a serum sample was collected and at 5:58 pm indicated the patient was positive for pregnancy: reference range and units is <=4 miu/ml.Result was 9^ and the flag was h.Final result: abnormal.Upon request for clarification, the customer only stated the result was 9 and flagged as high.Per the customer, the patient did not want to be pregnant.Counseling was provided and options given to the patient.Troubleshooting was conducted with the customer.The limitations of the test per the package insert were reviewed regarding testing a sample below the level of detection as well as the negative test interpretation section.
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