BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

    MDR report key: 20301470 · Received September 25, 2024

    Report

    Report Number
    2024800-2024-00016
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 15, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED LOGS PROVIDED BY THE CUSTOMER. HOLOGIC DID NOT IDENTIFY ANY HARDWARE OR REAGENT PREPARATION ISSUES AND DETERMINED THAT THE POSITIVE SAMPLES IN QUESTION WERE MISHANDLED. HOLOGIC TECHNICAL SUPPORT RELAYED THE FINDING TO THE CUSTOMER AND ADVISED TO PERFORM MONTHLY MAINTENANCE AND CLEAN SAMPLE AND REAGENT PREPARATION AREAS, AND TOUCH POINTS WITH FRESH CLEANING SOLUTION. ADDITIONALLY, HOLOGIC TS ADVISED CUSTOMER TO RUN BLANK SAMPLES TO RULE OUT CONTAMINATION. CUSTOMER CONFIRMED THAT THEY PERFORMED MONTHLY MAINTENANCE AND ENVIRONMENTAL TESTS GENERATED NEGATIVE RESULTS. CUSTOMER CONFIRMED THE INITIAL NEGATIVE SARS RESULTS WERE NOT AMENDED. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL SARS-COV-2 ASSAY QUESTIONING RESULTS AND FALSE RESULTS (CONFIRMED OR NOT) COMPLAINTS TO BE REPORTED AS MALFUNCTION MDR. OTHER.

    Description of Event or Problem · 0

    ON SEPTEMBER 4TH, 2024, CUSTOMER REPORTED TO HOLOGIC OBTAINING DISCREPANT RESULTS DURING VALIDATION/CORRELATION STUDIES WITH THE LDT-SARS-COV-2 ASSAY (CARTRIDGE LOT 746919) ON THE PANTHER FUSION INSTRUMENT SN (B)(6). SAMPLES, THAT INITIALLY TESTED SARS NEGATIVE MONTHS AGO, WERE PULLED FROM STORAGE AND RESULTED SARS POSITIVE WHEN RETESTED ON AUGUST 15TH, 2024, IN LDT-SARS-COV-2 WORKLIST 010064-20240815-202. CUSTOMER CONFIRMED THE RETESTED SAMPLES WERE FROM DIFFERENT ALIQUOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097821 PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown