BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 12958383 · Received December 8, 2021

    Report

    Report Number
    2024800-2021-00046
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 7, 2021
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE LOGS AND INFORMED THE CUSTOMER THE HARDWARE AND ASSAY WERE PERFORMING PROPERLY WHEN THE SAMPLES WERE TESTED. CUSTOMER CONFIRMED A NEW ALIQUOT WAS TAKEN FROM THE PRIMARY TUBE AS THE "PERKIN ELMER COMBO ASSAY" PERFORMED AT THE OTHER TESTING SITE CANNOT RUN ON THE APTIMA SAMPLE TUBES. THE CUSTOMER WILL NOT AMEND ANY RESULTS AS THEY ARE SATISFIED THE PANTHER AND SARS TMA ASSAY WERE PERFORMING PROPERLY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THEY HAVE A POSITIVE SARS-COV-2 TEST RESULT FROM WORKLIST ID 000488-20211021-01 USING MASTER LOT 296997 ON THE PANTHER INSTRUMENT SN (B)(4). HOWEVER, THE SAMPLE WAS SENT TO ANOTHER TESTING SITE AND CAME BACK WITH A NEGATIVE RESULT. CUSTOMER CONFIRMED A NEW ALIQUOT WAS TAKEN FROM THE PRIMARY TUBE AS THE "PERKIN ELMER COMBO ASSAY" PERFORMED AT THE OTHER TESTING SITE CANNOT RUN ON THE APTIMA SAMPLE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862422 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 296997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown