BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SD BIOSENSOR. REF: 9901-NCOV-10G

    MDR report key: 14167753 · Received April 20, 2022

    Report

    Report Number
    MW5109202
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 18, 2022
    Manufacturer
    SD BIOSENSOR, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TESTED POSITIVE WITH THE ROCHE/SD BIOSENSOR AT HOME COVID TEST KIT, NEGATIVE WITH 2 OTHER BRANDS OF TEST KITS. NEXT DAY, PCR TESTED AT (B)(6) LABS THROUGH (B)(6), CAME BACK NEGATIVE; 2 DAYS LATER, USED ANOTHER ROCHE/SD BIOSENSOR TEST FROM SAME KIT, WAS POSITIVE. NEXT DAY TESTED WITH THE IHEALTH COVID AT HOME TEST, IT WAS NEGATIVE. THE ONLY 2 POSITIVES WERE THE ROCHE/SD BIOSENSOR TESTS. I HAVE NO SYMPTOMS. THEY ARE FALSE POSITIVES FROM THE SAME KIT. ONLY THE 2 SD BIOSENSOR TESTS GAVE ME POSITIVE COVID TEST RESULTS OVER A 3 DAY PERIOD; 4 OTHER AT HOME TESTS BY IHEALTH AND ABBOTT, WERE NEGATIVE, AS WAS MY AEGIS LABS PCR COVID TEST WAS NEGATIVE. I HAVE NO SYMPTOMS. (I AM ALSO A SCIENTIST AND I KNOW THIS DOESN'T MAKE SENSE UNLESS THE SD BIOSENSOR KITS ARE BAD.) SD BIOSENSOR DISTRIBUTED BY ROCHE DIAGNOSTICS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715591 SD BIOSENSOR. REF: 9901-NCOV-10G REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR SD BIOSENSOR, INC. ROCHE ORDER NO: 09666672160 53K32A1T1/ SUB : 1-BUFFER : 53
    2715592 SD BIOSENSOR. REF: 9901-NCOV-10G REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR SD BIOSENSOR, INC. ROCHE ORDER NO: 09666672160 53K32A1T1/ SUB : 1-BUFFER : 53

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female FOSAMAX| VITAMINS