BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 15147231 · Received August 2, 2022

    Report

    Report Number
    2024800-2022-00567
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    July 2, 2021
    Report Date
    August 2, 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 NO INSTRUMENT OR REAGENT PREPARATION ISSUES, CONCLUDING THAT THE SAMPLES WERE LIKELY LOW-TARGET OR CONTAMINATED. CUSTOMER RAN ENVIRONMENTAL SWABS WHICH ALL CAME BACK NEGATIVE AND CONTINUED TO MONITOR. NO FURTHER ISSUES REPORTED. HOLOGIC AND FDA MET ON (B)(6)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 (B)(4) ), APTIMA SARS-COV-2 ((B)(4)), AND APTIMA SARS-COV-2/FLU (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)2022 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE SARS-COV-2 TMA RUN, WL 003376-20210627-02, USING ASSAY LOT 290566 ON PANTHER INSTRUMENT SN (B)(4) WHICH HAD 3 POOLED SAMPLES THAT DID NOT REPEAT WHEN RETESTED. THE SAMPLES WERE INITIALLY LOW POSITIVES, BUT THE INDIVIDUAL SAMPLES WERE RUN ON OTHER PANTHERS AND RESULTED NEGATIVE. CUSTOMER ALIQUOTED AND RAN SAMPLES A THIRD TIME, BUT THEY ALL RESULTED NEGATIVE AGAIN. 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
    2064035 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 290566

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown