BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 13260639 · Received January 14, 2022

    Report

    Report Number
    2024800-2022-00014
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 10, 2021
    Report Date
    January 14, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED THE LOGS FOR WORKLIST (B)(4) AND DID NOT FIND ANY REAGENT ERRORS OR INSTRUMENT HARDWARE ISSUES. HOLOGIC NOTED THAT SAMPLES MAY HAVE BEEN CONTAMINATED DURING TRANSPORTATION TO THE LAB OR INSIDE THE LAB BEFORE LOADING ON THE PANTHER INSTRUMENT. THE CUSTOMER CONFIRMED THAT RESULTS WERE REPORTED OUT, BUT THE PATIENTS DID NOT RECEIVE TREATMENT; HOWEVER, PATIENTS WERE QUARANTINED FOR TWO DAYS. HOLOGIC ADVISED THE CUSTOMER TO PERFORM MONTHLY MAINTENANCE AND REPLACE INSTRUMENT FLUIDS. THE CUSTOMER REPORTED AN IMPROVEMENT AFTER MAINTENANCE AND FLUID REPLACEMENT BUT CONTINUED EXPERIENCING POTENTIAL FALSE POSITIVE RESULTS. TS ADVISED THE CUSTOMER TO CLEAN ALL LABORATORY SURFACES AND PERFORM A PANEL RUN AFTER CLEANING. THE CUSTOMER INFORMED FIELD APPLICATION SPECIALIST (FAS) THAT MONTHLY MAINTENANCE WAS PERFORMED TWICE, LABORATORY SURFACES WERE CLEANED, AND INSTRUMENT FLUIDS WERE REPLACED. SOME IMPROVEMENT WAS NOTED, AND THE LAB SAID THEY WOULD CONTINUE TO CLEAN AND RUN TEN PANEL A'S IN EACH RUN FOR A FEW DAYS TO MONITOR. A FAS FOLLOWED UP WITH THE CUSTOMER ON 01/05/2022 AND THE CUSTOMER REPORTED NO ADDITIONAL POTENTIAL FALSE POSITIVE RESULTS SINCE CLEANING THE INSTRUMENT AND THE LABORATORY. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL LOGS OR WORKLISTS FOR REVIEW. NO PRODUCT IMPACT IS KNOWN TO DATE. A REVIEW OF THE CUSTOMER DATA DID NOT REVEAL ANY REAGENT OR INSTRUMENT ISSUES. THIS COMPLAINT RELATES TO A CONTAMINATION EVENT.

    Additional Manufacturer Narrative · 0

    INCORRECT DATE OF EVENT ((B)(6) 2021) FROM SECTION B3 WAS REPORTED ON THE INITIAL REPORT. THE CORRECT DATE SHOULD BE (B)(6) 2021.

    Description of Event or Problem · 0

    ON 12/10/2021 HOLOGIC RECEIVED A COMPLAINT REGARDING POTENTIAL FALSE POSITIVE APTIMA SARS-COV-2 RESULTS ON PANTHER SERIAL NUMBER (B)(4). THE CUSTOMER REPORTED AN INCREASE IN POSITIVE SARS-COV-2 SAMPLES AND SUSPECTED FALSE POSITIVE RESULTS. THE CUSTOMER NOTED THAT RESULTS CANNOT BE CONFIRMED WHEN SAMPLES ARE TESTED A SECOND TIME ON A DIFFERENT PANTHER OR PLATFORM. CUSTOMER WAS USING ASSAY MASTER LOT 308646. THE CUSTOMER PROVIDED PANTHER APTIMA SARS-COV-2 ASSAY WORKLIST 000166-20211203-34 IN WHICH THEY INDICATED 27 POTENTIAL FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    SEE H10 FOR COMMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730375 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 308646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown