BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 15113789 · Received July 27, 2022

    Report

    Report Number
    2024800-2022-00553
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    October 6, 2020
    Report Date
    July 27, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND FOUND EVIDENCE OF KIT PREPARATION MISHANDLING. PAS ADVISED TO CLEAN THE WORKSPACES AND COMMON TOUCH POINTS. CUSTOMER INFORMED THAT THEY TRACED THE SPIKE IN POSITIVITY IN THE WL IN QUESTION TO ONE OPERATOR. NO FURTHER ISSUES REPORTED. HOLOGIC AND FDA MET ON OCTOBER 29, 2021, REGARDING HOW TO REPORT ALL "FALSE/DISCREPANT/QUESTIONING RESULTS" COMPLAINTS FOR THE APTIMA AND PANTHER FUSION SARS-COV-2 ASSAYS (PANTHER FUSION SARS-COV-2 (EUA(B)(4)), APTIMA SARS-COV-2 (EUA(B)(4)), AND APTIMA SARS-COV-2/FLU (EUA(B)(4)). FDA CLARIFIED THAT AS PART OF THE CONDITIONS FOR THE EMERGENCY USE AUTHORIZATION OF SARS-COV-2 ASSAYS, MANUFACTURERS ARE REQUIRED TO TRACK ADVERSE EVENTS INCLUDING ANY OCCURRENCE OF "FALSE/DISCREPANT/QUESTIONING RESULTS", CONFIRMED OR UNCONFIRMED, AND REPORT TO FDA IN ACCORDANCE WITH 21 CFR PART 803. HOLOGIC, RETROSPECTIVELY IS REPORTING COMPLAINTS INITIATED FROM (B)(6) 2020 TO PRESENT.

    Description of Event or Problem · 0

    HOLOGIC FIELD APPLICATION SPECIALIST (FAS) REPORTED ON BEHALF OF CUSTOMER AN INCREASED POSITIVITY RATE ON THEIR SARS-COV-2 TMA RUNS USING ASSAY LOT 278953 ON PANTHER INSTRUMENT SN (B)(4). THEY WERE UNSURE IF THERE WAS A SPIKE IN SARS-COV-2 IN THE AREA OR IF THE ISSUE WAS DUE TO THE AIR CONDITIONER UNIT ABOVE THEIR SARS SAMPLES. ALL ENVIRONMENTAL SWABS ON THE INSTRUMENT WERE NEGATIVE. HOLOGIC PRODUCT APPLICATION SPECIALIST (PAS) REVIEWED WL 002976-20201007-12 TO IDENTIFY ANY POTENTIAL CONTAMINATION; THE WL HAD 14 POSITIVES OUT OF 66 SAMPLES. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. THERE WAS NO INDICATION OF RESULTS BEING REPORTED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082348 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 278953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown