BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY

    MDR report key: 13389876 · Received January 29, 2022

    Report

    Report Number
    2024800-2022-00035
    Event Type
    Malfunction
    Date Received
    January 29, 2022
    Date of Event
    November 29, 2021
    Report Date
    January 29, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC PRODUCT APPLICATION SPECIALIST (PAS) REVIEWED THE LOGS AND NOTED THAT THERE WERE NO INSTRUMENT ISSUES AND IT APPEARS THE PANEL B DOES HAS LOW TARGET. CUSTOMER WAS NOTIFIED OF THE FINDINGS AND REPORTED THAT THEY AGREE THAT THE INFLUENZA B WAS A LOWER CONCENTRATION THAN INFLUENZA A. CUSTOMER NOTED THAT THEY DIDN'T HAVE ENOUGH FLU B REFERENCE MATERIAL REMAINING TO MAKE A STRONGER CONCENTRATION. CUSTOMER WAS ADVISED TO RERUN THEIR VALIDATION WITH A HIGHER CONCENTRATION STOCK.

    Description of Event or Problem · 0

    CUSTOMER REPORTED GETTING A DISCREPANT SAMPLE FROM WORKLIST 000942-20211117-17 FOR SARS-COV-2/FLU (ASSAY ML 303906) ON THE PANTHER INSTRUMENT SN (B)(4). CUSTOMER NOTED THAT THE SAMPLES WERE EITHER PREVIOUSLY TESTED OR CONTRIVED. SAMPLES HAVE NOT BEEN TESTED FOR FLU BEFORE BUT THE SAME SAMPLES WERE TESTED ON THEIR OTHER PANTHER AND THE RESULTS WERE GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762977 APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY QLT HOLOGIC INCORPORATED 303906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown