BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANTHER INSTRUMENT

    MDR report key: 15581997 · Received October 11, 2022

    Report

    Report Number
    2024800-2022-01098
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 11, 2022
    Report Date
    October 11, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OOI
    UDI-DI
    15420045504141
    PMA / PMN Number
    K171963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT HAPPENED ON (B)(6) 2022 INVOLVED RESPIRATORY AND SARS-COV-2 LDT ASSAY ON THE SAME PANTHER INSTRUMENT SN: (B)(4) WAS A SECOND CONTAMINATION EVENT ON THE SAME CUSTOMER SITE. CPT- (B)(4) WAS INITIATED TO DOCUMENT THE SECOND CONTAMINATION EVENT. UNDER CPT-(B)(4) IT WAS FOUND THAT THE SAMPLE SHIELD ON BOARD WAS WARPED REDUCING THE PIPETTOR CLEARANCE OF THE SHIELD RESULTING IN POTENTIAL CONTACT OCCURRING BETWEEN THE SHIELD AND THE SAMPLE TIP. CUSTOMER CONFIRMED THAT NO WARPED SAMPLE SHIELDS WERE IDENTIFIED DURING THE 1ST CONTAMINATION EVENT. HOLOGIC FIELD APPLICATION SPECIALIST (FAS) NOTED THAT ENVIRONMENTAL CONTAMINATION COULD POTENTIALLY BE CAUSED FROM NOT CHANGING GLOVES AND SAMPLES BEING IN CONTACT WITH CLEAN REAGENT PREP AREAS. THE POST-CLEANING ENVIRONMENTAL RUN RESULTED IN NO FURTHER INDICATION OF CONTAMINATION. HOLOGIC DETERMINED THAT PANTHER SN: (B)(4) IS NO LONGER CONTAMINATED. HOLOGIC ALSO RECOMMENDED REFRESHER AND PROFICIENCY TRAINING FOR THE PANTHER FUSION SYSTEM IN THE LABORATORIES TO ENSURE THE EFFICACY OF THE SYSTEM AND OPERATOR EXPERTISE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CUSTOMER CONTACTED HOLOGIC REGARDING AN INCREASED POSITIVE RATE AND DISCREPANT RESULTS PRODUCED BY THE FUSION SARS-COV-2, FUSION ADV/HMPV/RV (AMR), FUSION PARAFLU, AND FUSION FLU A/B/RSV ASSAYS INITIALLY RAN ON PANTHER SN 03517. THE CUSTOMER RETESTED SAMPLES ON A DIFFERENT PLATFORM FOR SARS-COV-2 AND ON THE PANTHER FUSION FOR FUSION FLU, AMR, AND PARAFLU WHICH PRODUCED SEVERAL DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351952 PANTHER INSTRUMENT IN-VITRO DIAGNOSTIC OOI HOLOGIC, INC. COMMON 15420045504141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown