BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANORA COLLECTION KIT

    MDR report key: 7208997 · Received January 19, 2018

    Report

    Report Number
    MW5074677
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 20, 2017
    Report Date
    December 21, 2017
    Manufacturer
    NATERA
    Product Code
    KIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON OPENING THE ANORA, NATERA, SINGLE NUCLEOTIDE POLYMORPHISM (SNP) MICROARRAY CHROMOSOME ANALYSIS COLLECTION KIT IN THE OPERATING ROOM, I NOTICED THE SPECIMEN CONTAINER INSIDE THE KIT DID NOT HAVE NSS SOLUTION IN IT. IT APPEARED THE SOLUTION HAD LEAKED UT BECAUSE THERE WERE STILL DROPLETS OF A SOLUTION INSIDE THE CONTAINER. I DECIDED TO DISCARD THE KIT AND USE A NEW NATERA KIT AS I WASN'T SURE IF THE CONTAINER INTEGRITY HAD BEEN COMPROMISED. MISCARRIAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48592 ANORA COLLECTION KIT KIT, CULTURE, CHROMOSOME. KIQ NATERA ANORA FRESH E08118,7067962,F013019,1864553

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR