A 57-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 (b)(6) 2022.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 13.7 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 2.4, 27 days after the initial result report.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.However, the subject had no change in management, or increased follow-up with no biopsy performed.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)(4) 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.
|