BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANORA

    MDR report key: 7230584 · Received January 30, 2018

    Report

    Report Number
    MW5074986
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Date of Event
    January 26, 2018
    Report Date
    January 29, 2018
    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) MICROASSAY CHROMOSOME ANALYSIS COLLECTION KIT IN THE OPERATING ROOM, IT WAS DISCOVERED THAT THE SPECIMEN CONTAINER DID NOT CONTAIN ANY SOLUTION. A SUBSEQUENT KIT WAS OPENED TO ACQUIRE THE NEEDED SOLUTION. THE INVOLVED TEST KIT WAS UTILIZED ON FRIDAY (B)(6) 2018 AND SUBSEQUENTLY MAILED FOR PROCESSING. ADD'L INFO AVAILABLE FROM THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73275 ANORA MISCARRIAGE TEST KIT KIQ NATERA ANORA FRESH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR