BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

    MDR report key: 20615032 · Received November 5, 2024

    Report

    Report Number
    2024800-2024-00032
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 7, 2024
    Report Date
    November 5, 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 TECHNICAL SUPPORT (TS) REVIEWED THE WORKLIST AND NOTED NO HARDWARE, SOFTWARE, OR KIT-RELATED ISSUES. CUSTOMER SUSPECTED THAT EXCESSIVE ENVIRONMENTAL HEAT COULD BE A CONTRIBUTING FACTOR TO THE QUESTIONED RESULTS. TS NOTED THAT ALTHOUGH THE CUSTOMER WAS UNABLE TO PROVIDE THE OPERATING TEMPERATURE ON THE AFFECTED DAY, THE TEMPERATURE FLUCTUATIONS WERE NOT THE CAUSE FOR THE INCREASED PREVALENCE OF POSITIVE RESULTS. TS NOTED THE SAMPLES WERE EITHER LOW TARGET OR MISHANDLED. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL APTIMA 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

    CUSTOMER PERFORMED A PANTHER FUSION SARS-COV-2 RUN, WORKLIST: 000541-20241002-09 (REPORTED TO HOLOGIC ON 10/07/2024), USING CARTRIDGE LOT 746919 ON PANTHER FUSION PLUS INSTRUMENT SERIAL NUMBER (B)(6) WHICH HAD 12 QUESTIONED RESULTS. CUSTOMER NOTED THAT THE RESULTS WERE QUESTIONED BY THE INFECTION CONTROL DEPARTMENT AND ALL THE SAMPLES WERE RETESTED USING A NEW ALIQUOT ON A NON-HOLOGIC PLATFORM, GENEEXPERT. ALL RETESTED SAMPLES RETURNED WITH NEGATIVE RESULTS AND WERE NOT REPORTED OUT. CUSTOMER NOTED THAT THE INITIAL REPORTED RESULTS WERE NOT AMENDED. CUSTOMER DID NOT MENTION BEING AWARE OF ANY TREATMENT PROVIDED TO PATIENTS. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. THERE WERE NO REPORTED OR ASSOCIATED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991153 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