BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14606127 · Received June 6, 2022

    Report

    Report Number
    2024800-2022-00401
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    January 13, 2021
    Report Date
    June 6, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND FOUND NO ISSUES WITH REAGENT PREPARATION OR CONTROLS RLUS FOR THE WL IN QUESTION AND THE RETEST. TS CONCLUDED THE RESULT WAS LIKELY CAUSED BY SAMPLE MISHANDLING, LOW TARGET SAMPLE, AND/OR VARIANCES IN SAMPLE COLLECTION. HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND AGREED WITH TS'S FINDINGS; SINCE THE SAMPLES WERE FROM TWO DIFFERENT TUBES, THEIR RESULTS SHOULD NOT BE COMPARED. 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 (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 MARCH 16, 2020 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE SARS-COV-2 TMA RUN, WL 002285-20210111-08, USING ASSAY LOT: 278953 ON PANTHER INSTRUMENT SN: (B)(4), WHICH HAD A DISCREPANT SAMPLE. CUSTOMER QUESTIONED ONE POSITIVE SAMPLE FROM THE WL IN QUESTION AND COLLECTED A SECOND SAMPLE WHICH WAS NEGATIVE WHEN RETESTED ON A PANTHER. CUSTOMER NOTED THEY USE BOTH CAPPED AND UNCAPPED WORKFLOW. THE SAMPLE CAME FROM A PRE-OP PATIENT WHOSE TREATMENT WAS THEN CANCELLED BECAUSE OF THE POSITIVE TEST RESULT. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. THE POSITIVE RESULT WAS REPORTED OUT PER PUBLIC HEALTH GUIDELINES AND HAD NO ASSOCIATED/REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578115 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 278953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown