BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROM PLUS

    MDR report key: 6958282 · Received October 18, 2017

    Report

    Report Number
    6958282
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 10, 2017
    Report Date
    September 18, 2017
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN COLLECTING THIS PATIENT'S SPECIMEN, THE RN NOTED THAT THE BUFFER VIAL DID NOT CONTAIN LIQUID BUFFER. THE RN OBTAINED ANOTHER COLLECTION KIT AND COLLECTED THE SPECIMEN AND SUBMITTED IT TO THE LAB FOR TESTING. THE RN EXAMINED THE REMAINING COLLECTION KITS AND FOUND 1 ADDITIONAL BUFFER VIAL THAT WAS EMPTY. THIS WAS REPORTED TO THE LAB AND THEY ALSO FOUND 1 OF THE SAME LOT NUMBER WITH AN EMPTY BUFFER VIAL AS WELL. MANUFACTURER RESPONSE FOR ROM PLUS COLLECTION DEVICE, (BRAND NOT PROVIDED) (PER SITE REPORTER). NOTHING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737793 ROM PLUS IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S) NQM CLINICAL INNOVATIONS, LLC ROM-6025 170593

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR