BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD

    MDR report key: 11701536 · Received April 21, 2021

    Report

    Report Number
    2243471-2021-00892
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 21, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    QHO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED WITH KIT LOTS E18109, E16111, E15557, 336610 DURING THE COURSE OF THE INVESTIGATION. THE MATERIAL NUMBER FOR THE COBAS TAQSCREEN MPX TEST, V2.0 US-IVD: 05969484190. (B)(4)

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) REPORTED THE POSSIBILITY OF A (B)(6) WITH THE COBAS TAQSCREEN MPX TEST, V2.0, WHICH WAS USED TO TEST DONATION(S) TRANSFUSED INTO A THALASSEMIC RECIPIENT. (B)(6). THE CUSTOMER DID NOT PROVIDE OTHER INFORMATION OR EVIDENCE THAT INDICATES THAT THE RECIPIENT'S (B)(6) IS RELATED TO THE PREVIOUSLY TESTED BLOOD DONATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600204 COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV QHO ROCHE MOLECULAR SYSTEMS, INC. NA 336610

    Patients

    Seq Age Sex Outcome Treatment
    1