BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 13561070 · Received February 18, 2022

    Report

    Report Number
    2024800-2022-00054
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 21, 2022
    Report Date
    February 18, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC PRODUCT APPLICATION SPECIALIST (PAS) REVIEWED THE LOGS AND FOUND NO HARDWARE OR REAGENT PREPARATION ISSUES THAT WOULD HAVE CAUSED THE DISCREPANT RESULT. THE SAMPLES WERE ALSO RAN USING DIFFERENT COLLECTION TUBES AND NOT THE SAME EXACT TUBE WHEN RETESTED. CUSTOMER WAS INFORMED THAT THESE WOULD NOT BE CONSIDERED DISCREPANT. THE INSTRUMENT AND ASSAY APPEAR WERE WORKING AS EXPECTED.

    Description of Event or Problem · 0

    CUSTOMER CALLED HOLOGIC QUESTIONING A SARS-COV-2 SAMPLE RESULT FROM WL-010337-20211231-06 ON THE PANTHER INSTRUMENT SN (B)(4). CUSTOMER USED ASSAY LOT 296997. SAMPLE INITIALLY TESTED POSITIVE AND NEGATIVE UPON RETEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530452 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 296997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown