BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4KSCORE TEST

    MDR report key: 16839260 · Received April 28, 2023

    Report

    Report Number
    3003652672-2022-00106
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    October 19, 2022
    Report Date
    April 28, 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

    PLEASE REFER TO MDR MANUFACTURER NO. 3003652672-2022-00001 FOR FULL DETAILS FOR PARTS D, E, G AND H THAT ARE COMMON, OTHER THAN THOSE FIELDS COMPLETED HEREIN WHICH ARE SPECIFIC TO THIS INDIVIDUAL SUBJECT CASE OR REQUIRED. THERE WAS ONE DEVICE MALFUNCTION THAT IMPACTED INDIVIDUAL 662 4KSCORE TEST RESULTS BETWEEN AUGUST 29, 2022 AND NOVEMBER 15, 2022.

    Description of Event or Problem · 0

    A 76-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 40.4 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 9.7, 29 DAYS AFTER THE INITIAL RESULT REPORT. THE SUBJECT HAD UNKNOWN/HEALTHCARE PROVIDED AS THE PHYSICIAN DECLINED TO PROVIDE FOLLOW-UP. 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, NEITHER THE PMA HOLDER NOR THE MANUFACTURER HAS NOT RECEIVED OR IS AWARE OF ANY UNTOWARD EVENTS/EFFECTS AS A RESULT OF THIS DEVICE MALFUNCTION AND ERRANT INITIAL 4KSCORE TEST RESULTS. PLEASE REFER TO MDR MANUFACTURER NO. 3003652672-2022-00001 FOR FULL DETAILS FOR PARTS D, E, G AND H THAT ARE COMMON, OTHER THAN THOSE FIELDS COMPLETED HEREIN WHICH ARE SPECIFIC TO THIS INDIVIDUAL SUBJECT CASE OR REQUIRED. THERE WAS ONE DEVICE MALFUNCTION THAT IMPACTED INDIVIDUAL 662 4KSCORE TEST RESULTS BETWEEN AUGUST 29, 2022 AND NOVEMBER 15, 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363756 4KSCORE TEST 4K QRF

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other