BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MPX TEST, CE-IVD

    MDR report key: 11958699 · Received June 8, 2021

    Report

    Report Number
    2243471-2021-01678
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 6, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING; A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(6). THE MATERIAL NUMBER FOR THE COBAS MPX TEST, 96 T US-IVD IS 06998909190. (B)(4).

    Additional Manufacturer Narrative · 0

    NO PRODUCT ISSUE WAS IDENTIFIED DURING THE COURSE OF THE INVESTIGATION OF THE KIT LOT. ALTHOUGH IT COULD NOT BE CONFIRMED, THE REACTIVE RESULTS GENERATED MAY BE TRULY RELATED TO HIV SEQUENCES IN THE SAMPLE, OF UNCLEAR ORIGIN. THESE REACTIVE RESULTS COULD REPRESENT SAMPLE CONTAMINATION IF BOTH TUBES ARE FROM THE SAME SOURCE OR WERE OPEN IN THE LAB AT THE SAME TIME. ROCHE MEDICAL AFFAIRS DEPARTMENT NOTED THAT THERE ARE ALSO OTHER POSSIBILITIES OF SOURCES OF HIV SEQUENCES, FOR EXAMPLE, IF THE DONOR WAS TREATED WITH GENE THERAPY PRIOR TO THE COLLECTION OF THE (B)(6) 2021 SAMPLE. SOME GENE THERAPY METHODS USE VECTORS CONTAINING HIV LTR SEQUENCES. HOWEVER, THIS COULD NOT BE VERIFIED. SAMPLE MATERIAL OF THE DONOR IN QUESTION WAS REQUESTED BUT WAS NOT AVAILABLE FOR FURTHER EVALUATION AND ANALYSIS. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) ALLEGED (B)(6) RESULTS FOR A STEM CELL DONATION TESTED WITH THE COBAS MPX TEST (LOT G17787). THE STEM CELLS WERE TRANSPLANTED AND THERE IS NO INDICATION OF HARM TO ANY RECIPIENT. THE INVESTIGATION IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853226 COBAS MPX TEST, CE-IVD ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G17787

    Patients

    Seq Age Sex Outcome Treatment
    1