BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14197327 · Received April 25, 2022

    Report

    Report Number
    2024800-2022-00149
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 25, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PAS REVIEWED THE LOGS AND DID NOT FIND ANY HARDWARE ERRORS OR PREPARATION ISSUES THAT WOULD HAVE AFFECTED THE RESULTS. OVERALL, THE INSTRUMENT APPEARS TO BE RUNNING WELL. HOLOGIC COULD NOT COMMENT ON THE CUSTOMER'S POSITIVITY RATE, WHICH APPEARS LOW, AS IT WAS NOTED BY THE CUSTOMER THAT THEY MAY NOT RUN ALL SAMPLES ON THE PANTHER INSTRUMENT.

    Description of Event or Problem · 0

    CUSTOMER REQUESTED A REVIEW OF SARS-COV-2 RUN, WL 002647-20220325-01 BECAUSE CUSTOMER'S LABORATORY SARS-COV-2 POSITIVITY RATE WAS LOWER THAN OTHER LABORATORIES. CUSTOMER USED ASSAY LOT 316798 ON THE PANTHER INSTRUMENT SN (B)(4). CUSTOMER REPORTED NOT HAVING RAW DATA TO SEE WHICH INSTRUMENT THE PATIENT'S SAMPLES WERE RAN ON EITHER PANTHER OR CEPHEID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953055 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 316798

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown