BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDSCREEN RS-2000D AND RS-DIGITAL

    MDR report key: 716559 · Received May 18, 2006

    Report

    Report Number
    3005156333-2006-00001
    Event Type
    Malfunction
    Date Received
    May 18, 2006
    Manufacturer
    RIVERAIN MEDICAL
    Product Code
    MYN
    PMA / PMN Number
    P000041
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON APRIL 24, 2006, A CONTROL FILE ERROR WITH RESPECT TO THE RAPIDSCREEN RS-2000D AND RS-DIGITAL DEVICE WAS DISCOVERED DURING A CLINICAL STUDY BEING CONDUCTED FOR A PMA SUPPLEMENTAL SUBMISSION. THE CONTROL FILE ERROR RESULTS IN SENSITIVITY AND SPECIFICITY THAT DIFFER FROM THE PMA-APPROVED PRODUCT SPECIFICATIONS FOR THE DEVICE. SPECIFICALLY, THE PRODUCT THAT WAS PLACED INTO COMMERCIAL DISTRIBUTION HAS A SENSITIVITY OF 57% AND A SPECIFICITY OF 3.97 (FALSE POSITIVES PER IMAGE), WHICH DIFFERS FROM THE FDA-APPROVED PRODUCT, WHICH HAS A SENSITIVITY OF 63.3% AND A SPECIFICITY OF 5.0. THUS, THERE IS A DIFFERENCE OF 6.3% IN SENSITIVITY AND OF 1.03 IN SPECIFICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 RAPIDSCREEN RS-2000D AND RS-DIGITAL COMPUTER AIDED DETECTION SYSTEM (CAD) MYN RIVERAIN MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *