A 72-year-old male with a history of high level of prostate specific antigen (psa).Submitted a sample for 4kscore test analysis on (b)(6) 2022, which was conducted on the same day.The subject's urological history included a previous digital rectal exam without a prostate nodule present.The subject also had a previous biopsy that was negative.His 4kscore was 11.8 and this result was reported, to the requistioner/provider on (b)(6) 2022.Given the identification of the input error in the sample requisition intake software, his 4kscore was recalculated and reported, to the physician on (b)(6) 2022, with a revised 4kscore of 2.1, 23 days after the initial result report.Clinical follow-up: unknown/healthcare provider declined to provide follow-up.Given that the initial 4kscore result was 20, and decreased further upon recalculation to 10.There is a remote possibility that the subject, was subjected to additional and potentially unnecessary medical procedures which may include magnetic resonance imaging of the prostate and/or biopsy.And the risks associated with that, as deemed necessary by the attending physician.To date, neither the pma holder nor the manufacturer has received or is aware of any untoward events/effects as a result of this device malfunction and errant initial 4kscore test results.This one device malfunction impacted (b)(6) test results.Please refer to section h10 in manufacturer's report no.3003652672-2022-00001.For a complete discussion with respect to the late filing date and description of the device malfunction.
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