BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION SARS COV-2/FLU/RSV

    MDR report key: 20263844 · Received September 19, 2024

    Report

    Report Number
    2024800-2024-00014
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 22, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QOF
    UDI-DI
    15420045515352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) AND PRODUCT APPLICATION SUPPORT (PAS) REVIEWED LOGS FROM 08/19/24 TO 08/22/24 AND CONFIRMED THAT ON WL 003394-20240819-14, 3 OUT OF 38 SAMPLES PRODUCED POSITIVE FLU B/SARS-COV-2 RESULTS; FROM WL 003394-20240820-64, 6 OUT OF 53 SAMPLES PRODUCED POSITIVE FLU B/SARS-COV-2 RESULTS; FROM ON WL-003394-20240821-78, 6 OUT OF 24 SAMPLES PRODUCED POSITIVE FLU B/SARS-COV-2 RESULTS. TS REVIEWED THE POSITIVE SAMPLES IN QUESTION FROM THE INITIAL RUN AND NOTED THAT ALL POSITIVE RESULTS FOR FLU B AND SARS-COV-2 HAD >2000 RFU RANGE WITH THE THRESHOLD BEING 1000. BASED ON THE CURVES, TS OBSERVED THAT THE RESULTS APPEAR TO BE FALSE. THE CUSTOMER NOTED THAT THIS ISSUE IS RECENT, AS THEY HAVE BEEN RUNNING THE SARS/FLU A/B/RSV SINCE THE BEGINNING OF THE YEAR.HOLOGIC COMPLETED A RISK ASSESSMENT AND CONCLUDED THAT THE RISK OF CUSTOMER QUESTIONING RESULTS AND/OR THE RISK OF FALSE FLU B POSITIVE RESULT WHEN A PATIENT SAMPLE IS SARS-COV-2 POSITIVE IS BROADLY ACCEPTABLE.HOLOGIC INFORMED ALL QUEST SITES ABOUT CTB-01273 THAT THERE IS A POTENTIAL ERRONEOUS INFLUENZA B VIRUS (FLU B) POSITIVE RESULTS WHEN TESTING WITH THE PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY ON THE PANTHER FUSION SYSTEM. HOLOGIC IMPLEMENTED AN UPDATE TO THE CROSSTALK CORRECTION ALGORITHM OF THE PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY SOFTWARE. HOLOGIC CONFIRMED THAT THE SOFTWARE 7.2.7 VERSION FOR PANTHER FUSION SYSTEMS SN 2090003394 (08/28/24) AND SN 2090000527 (08/29/24)WERE UPGRADED. H3 OTHER TEXT : OTHER

    Description of Event or Problem · 0

    ON 08/22/2024, QUEST DIAGNOSTICS CUSTOMER SITE REPORTED TO HOLOGIC THAT THEY HAD FALSE POSITIVE FLU-B RESULTS ACROSS MULTIPLE WORKLISTS (WL) WHILE USING THE SARS/FLU A/B/RSV ASSAY (CARTRIDGE LN 887424) (ML 890419) ON PANTHER FUSION INSTRUMENT (SN (B)(6). CUSTOMER REPORTED MULTIPLE FLU B AND SARS-COV-2 DUAL POSITIVE RESULTS IN THE LAST FEW RUNS. CUSTOMER RETESTED THE ASSOCIATED SARS-COV-2 AND FLU B DUAL POSITIVE SAMPLES ON THEIR OTHER PANTHER FUSION INSTRUMENT (B)(6), WHICH RESULTED IN SARS-COV-2 POSITIVE AND FLU B NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226772 FUSION SARS COV-2/FLU/RSV PANTHER FUSION SARS COV-2/FLU A/B/RSV ASSAY QOF HOLOGIC, INC. 890419 15420045515352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown