BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4KSCORE TEST

    MDR report key: 16775327 · Received April 20, 2023

    Report

    Report Number
    3003652672-2022-00008
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    October 8, 2022
    Report Date
    April 18, 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 68-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 35.0 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 7.9, 39 DAYS AFTER THE INITIAL RESULT REPORT. GIVEN THAT THE INITIAL 4KSCORE RESULT WAS GREATER THAN 20 AND DECREASED UPON RECALCULATION, IT IS POSSIBLE 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, THE SPONSOR HAS NOT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613328 4KSCORE TEST 4K QRF

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other