BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14438274 · Received May 19, 2022

    Report

    Report Number
    2024800-2022-00290
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    October 12, 2020
    Report Date
    May 18, 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 FIELD APPLICATIONS SPECIALIST (PAS) DISCUSSED POSSIBLE CAUSES OF DISCREPANCIES (EX. ASSAY SENSITIVITY, SAMPLE STORAGE, ETC.). HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND FOUND MANY OF THE SAMPLES IN QUESTION HAD RLUS LOWER THAN THE CONTROLS, INDICATIVE OF LOW-TARGET SAMPLES. PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS, FOUND NO INSTRUMENT OR REAGENT PREPARATION ISSUES, AND AGREED WITH TS'S ASSESSMENT. MEDICAL SCIENCE LIAISON (MSL) INFORMED CUSTOMER THAT THE 7 SAMPLES IN QUESTION WERE LIKELY LOW POSITIVES, AND IT WAS IMPOSSIBLE TO KNOW WHETHER THE POSITIVES WERE FROM THE PATIENTS OR CONTAMINATION. CUSTOMER CONFIRMED THEY WERE NOT SEEING CONTAMINATION OUTSIDE OF THIS SET. 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) 2020 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE SARS-COV-2 TMA RUN, WL (B)(4) USING ASSAY LOT 279994 ON PANTHER INSTRUMENT SN (B)(4) WHICH HAD DISCREPANT SAMPLES. THE WL IN QUESTION HAD 27 POSITIVES OUT OF 133 SAMPLES. ANOTHER LAB RETESTED 7 OF THOSE SAMPLES USING A RAPID TEST METHOD (ALL NEGATIVE RESULTS), THEN RETESTED AGAIN VIA THERMO FISCHER TAQ PATH (ALL NEGATIVE RESULTS). CUSTOMER RETESTED THE 7 QUESTIONABLE SAMPLES BUT USED A LESS SENSITIVE PCR ASSAY, AND SPECIMENS HAD UNDERGONE MULTIPLE FREEZE/THAWS OVER 10 DAYS; ONLY 1 OF THE 7 ORIGINAL POSITIVES WAS CONFIRMED. NEGATIVE RESULTS WERE REPORTED TO PATIENTS BY THE OTHER LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893166 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 279994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown