BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST V2

    MDR report key: 12747023 · Received November 3, 2021

    Report

    Report Number
    2243471-2021-03629
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 7, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    UDI-DI
    00875197004045
    PMA / PMN Number
    BL125459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED WITH THE COMPLAINT KIT LOT DURING THE COURSE OF THE INVESTIGATION. THE SAMPLE IN QUESTION WAS SENT TO ROCHE FOR FURTHER ANALYSIS. THE SAMPLE WAS TESTED IN TRIPLICATE USING A QUANTITATIVE ROCHE TEST (COBAS HBV ASSAY). ONE OUT OF 3 REPLICATES GENERATED A <TITERMIN RESULT, WHILE THE OTHER 2 REPLICATES GENERATED TARGET NOT DETECTED RESULTS. BASED ON THE TESTING RESULTS AND ALL OF THE INFORMATION AVAILABLE IN THE CASE, IT IS LIKELY THAT THE SAMPLE CONTAINS A LOW CONCENTRATION OF HBV, WHICH IS NOT CONSISTENTLY DETECTED WITH THE COBAS TAQSCREEN MPX TEST V2.0. (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER IN THE (B)(6) ALLEGED THE GENERATION OF DISCREPANT (B)(6) RESULTS WITH THE COBAS TAQSCREEN MPX TEST, V2.0 FOR A PATIENT WHO GENERATED (B)(6) RESULTS ((B)(6)). THE PATIENT WAS BEING SCREENING FOR (B)(6) AS A NEWLY ARRIVED EXPAT. NO DONATION WAS INVOLVED AND NO HARM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641852 COBAS TAQSCREEN MPX TEST V2 HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H06830 00875197004045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown