Investigation conclusion: it is indicated that the product is not returning for evaluation.As the customer did not provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.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, the patient arrived at facility for a scheduled sonohysterogram (sono hsg).A urine sample was collected and produced a negative result using a consult hcg dipstick test.The sono hsg procedure was performed following the negative hcg result.The same day, a serum sample was collected and produced a positive quantitative hcg result of 241.1 mlu/ml on a roche diagnostics instrument.The patient's progesterone was also reported as 0.85.During a follow-up conducted on (b)(6) 2018, the customer stated the patient was currently undergoing a miscarriage.The miscarriage was referred to as "spontaneous" and the customer stated is it unknown whether the pregnancy was initially viable.However, no additional information was provided.The customer reported the event on behalf of a sister facility.
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