BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 13083524 · Received December 24, 2021

    Report

    Report Number
    2024800-2021-00080
    Event Type
    Malfunction
    Date Received
    December 24, 2021
    Date of Event
    November 11, 2021
    Report Date
    December 24, 2021
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TS REVIEWED THE LOGS AND FOUND NO HARDWARE, INSTRUMENT, OR REAGENT PREPARATION ISSUES THAT MIGHT HAVE LED TO AN INCREASE IN POSITIVITY FOR THE ASSAY RUN. TS ALSO OBSERVED THAT THE TOTAL RLU VALUES OF THE CONTROL WERE WELL WITHIN THE SPECIFICATION OF THE ASSAY. HOLOGIC PRODUCT APPLICATION SPECIALISTS (PAS) REVIEWED THE LOGS AND CONCLUDED THAT THE KINETICS, SAMPLE ASPIRATION, AND DISPENSE CURVES WERE NORMAL. ADDITIONALLY, THE RESULTS WERE NOTED TO HAVE BEEN RANDOM AND NOT CLUSTERED TOGETHER TO REPRESENT ANY SIGNS OF CONTAMINATION. PAS SUGGESTED THAT THE CUSTOMER PERFORM MONTHLY MAINTENANCE ON THEIR INSTRUMENT, ANALYZE ENVIRONMENTAL SWABS, AND RUN A MINIMUM 30 REPLICATES OF BLANK SAMPLES TO ELIMINATE CONTAMINATION AS A POTENTIAL CAUSE FOR THE INCREASED POSITIVITY. THE CUSTOMER OBTAINED NEGATIVE RESULTS FROM THE ENVIRONMENTAL TESTING AND A RUN WITH BLANK SAMPLES RUNS, INDICATING THERE WAS NO CONTAMINATION AT THE SITE. THE CUSTOMER OBSERVED THAT THE POSITIVITY RATE FOR THE SARS-COV-2 TESTING CONDUCTED ON (B)(6) 2021 RETURNED TO NORMAL AND AS EXPECTED. THE CUSTOMER HAS CONTINUED TO RUN AND HAS DECIDED NOT TO RETEST THE POSITIVE SAMPLES, SINCE THE RESULTS ARE DETERMINED TO BE TRUE POSITIVES RESULTS. THE RESULTS HAVE BEEN REPORTED TO THE PATIENT AS PER THE CUSTOMER'S LAB POLICIES AND NO FURTHER ISSUES HAS BEEN REPORTED TO THE TS. NO PRODUCT IMPACT IS KNOWN TO DATE.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A CUSTOMER CALLED HOLOGIC TECHNICAL SUPPORT (TS) TO REPORT THAT THEY WERE EXPERIENCING AN INCREASED RATE OF POSITIVE RESULTS ON PANTHER INSTRUMENT SN (B)(4) FROM SARS-COV-2 (LOT 307201) TESTING THEY CONDUCTED ON (B)(6) 2021 COMPARED TO THE NORMAL POSITIVE RATE PREVIOUSLY OBSERVED IN THEIR LAB. THE CUSTOMER IDENTIFIED THE SOURCE OF THE POSITIVELY TESTED SAMPLES WERE OBTAINED FROM SAME SITE. THE CUSTOMER NOTED 3 POSITIVE RESULTS OUT OF 100 TESTS ASSOCIATED WITH WORKLIST 001374-20211110-12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982152 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 307201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown