BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY

    MDR report key: 17219474 · Received June 28, 2023

    Report

    Report Number
    2024800-2023-00013
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 20, 2023
    Report Date
    June 26, 2023
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QOF
    UDI-DI
    15420045515352
    PMA / PMN Number
    K222736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED BOTH WORKLISTS AND NOTED NO HARDWARE ISSUES. CUSTOMER WAS WORRIED ABOUT RESIDUAL CONTAMINATION FROM A PREVIOUS CASE SO TS ADVISED THE CUSTOMER TO PERFORM MONTHLY MAINTENANCE AND RUN ONE RACK OF EMPTY LYSIS TUBES. CUSTOMER FOLLOWED THE ADVICE AND THE EMPTY LYSIS TUBES RESULTED AS NEGATIVE WHICH INDICATED NO RESIDUAL CONTAMINATION. HOLOGIC FIELD APPLICATION SPECIALIST ADVISED THE CUSTOMER TO NOT TOUCH THE ALUMINUM FOIL OF THE PENETRABLE CAPS WITH POTENTIALLY CONTAMINATED GLOVES. TS INFORMED THE CUSTOMER THAT TOUCHPOINT CONTAMINATION OF THE PIERCEABLE CAPS WAS LIKELY THE CAUSE OF THE ISSUE. CUSTOMER RETESTED THE NOW NEGATIVE RESULTING TUBES AGAIN AND OBTAINED A NEGATIVE RESULT. CUSTOMER THEN RETESTED THE SAMPLE IN THE SAME TUBE THAT PRODUCED THE POSITIVE RESULT BUT WITH A NEW PIERCEABLE CAP AND OBTAINED A NEGATIVE RESULT. CUSTOMER CONFIRMED LOCAL CONTAMINATION WAS LIKELY ON THE PIERCEABLE CAP DUE TO THESE RESULTS. 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. H3 OTHER TEXT : OTHER.

    Description of Event or Problem · 0

    CUSTOMER PERFORMED ONE SARS/FLUA/B/RSV RUN, WL: 000238-20230621-03 ((B)(62023), USING ASSAY LOT 343968 ON PANTHER FUSION INSTRUMENT SN (B)(6) WHICH HAD 2 QUESTIONING SAMPLES. CUSTOMER RETESTED 2 INITIALLY POSITIVE RESULTS (WL: 000238-20230619-07 ((B)(6)2023)) USING THE SAME SAMPLE TUBE WITH A NEW PIERCEABLE CAP, NEW SAMPLE ALIQUOT, AND SAME ASSAY LOT AND OBTAINED SUBSEQUENT NEGATIVE RESULTS FOR BOTH SAMPLES (WL: 000238-20230621-03 ((B)(6)2023). THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. CUSTOMER CONFIRMED THAT ONLY THE SUBSEQUENT NEGATIVE RESULT WAS REPORTED OUT. CUSTOMER DID NOT NOTE HAVING INFORMATION IF THE PATIENT RECEIVED TREATMENT BASED ON THE REPORTED RESULTS. THERE WERE NO ASSOCIATED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725893 PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY FUSION SARS COV-2/FLU/RSV QOF HOLOGIC, INC. 343968 15420045515352

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown