BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT ID NOW SARS COV-2 ASSAY

    MDR report key: 17247891 · Received June 30, 2023

    Report

    Report Number
    MW5119052
    Event Type
    Death
    Date Received
    June 30, 2023
    Date of Event
    September 21, 2021
    Report Date
    June 30, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) HOSPITAL USED A RECALLED COVID TESTING MACHINE, ABBOTT ID NOW, AFTER THE RECALL. MY FATHER WAS DIAGNOSED WITH COVID BUT THE TEST I RECEIVED ALMOST TWO YEARS LATER HAS DISCREPANCIES. HE DIED OF A "FALSE POSITIVE" COVID DIAGNOSIS ON (B)(6) 2021. PLEASE SEE ATTACHED DOCUMENTS WITH MY FATHER'S HEALTH INFORMATION AND CORRESPONDENCE WITH ABBOTT RAPID DIAGNOSTICS INC. PLEASE SEE ENCLOSED NOTES, ORDER #(B)(4). THANK YOU. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040594 ABBOTT ID NOW SARS COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| D| L ANTI-REJECTION KIDNEY MEDICATIONS | INSULIN| MAGNESIUM| MY FATHER TOOK ABOUT 29 PILLS A DAY AFTER HIS KIDNEY TRANSPLANT| VITAMIN D