BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® BKV (192)

    MDR report key: 20657013 · Received November 11, 2024

    Report

    Report Number
    2243471-2024-03266
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 15, 2024
    Report Date
    December 6, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLX
    PMA / PMN Number
    K203220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING,

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE WAS FOUND TO BE CUSTOMER HANDLING/WORKFLOW-RELATED ISSUES INCLUDING BUT NOT LIMITED TO THE FOLLOWING: SAMPLE STORAGE, SAMPLE PREP INCLUDING CENTRIFUGATION/VORTEXING, AND ALIQUOTING OF THE SAMPLE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE EBV RESULTS FOR ONE PATIENT SAMPLE USING THE COBAS® BKV ASSAY FOR USE ON THE COBAS 58/68/8800 SYSTEMS. ON (B)(6) 2024, THE ALLEGED SAMPLE HAD A RESULT OF 16,982 IU/ML. ON (B)(6) 2024, A NEW SAMPLE INITIALLY GENERATED A RESULT OF 224 IU/ML WHICH WAS QUESTIONED BY THE DOCTOR AND PROMPTED THE REPEAT. ON (B)(6) 2024, THE SAME SAMPLE WAS REPEATED AND A RESULT OF 79,600 IU/ML WAS GENERATED. THE DOCTOR INDICATED THIS ALIGNED CLOSER TO THE CLINICAL PICTURE. A NEW SAMPLE WAS OBTAINED FROM THE SAME PATIENT ON (B)(6) 2024 AND THE SAMPLE GENERATED A RESULT OF 16,218 IU/ML ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057053 COBAS® BKV (192) NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV) QLX ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown