BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4KSCORE TEST

    MDR report key: 16925073 · Received May 12, 2023

    Report

    Report Number
    3003652672-2022-00274
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    October 26, 2022
    Report Date
    May 11, 2023
    Manufacturer
    BIOREFERENCE HEALTH, LLC
    Product Code
    QRF
    PMA / PMN Number
    P190022
    Removal / Correction Number
    3003652672-04/12/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ONE DEVICE MALFUNCTION IMPACTED 662 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. PLEASE REFER TO THIS NOTED REPORT FOR ALL OTHER COMMON INFORMATION THAT IS NOT SPECIFIC TO THIS SUBJECT'S CASE.

    Description of Event or Problem · 0

    A 52-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 10.5 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 1.8, 22 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 662 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031638 4KSCORE TEST 4K QRF

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other