BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 13555327 · Received February 18, 2022

    Report

    Report Number
    2024800-2022-00052
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 21, 2022
    Report Date
    February 17, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TS REVIEWED THE LOGS WHICH DID NOT SHOW ANY HARDWARE ISSUE. THE REASON FOR THE DISCREPANT RESULTS MIGHT HAVE BEEN LOW POSITIVES, MUCOID SAMPLES, OR POINT CONTAMINATION. CUSTOMER RETESTED THE SAMPLES AND ON RETEST ONLY ONE SAMPLE (THE STRONGEST POSITIVE) RETESTED AS POSITIVE AND WAS REPORTED AS SUCH. TS PROVIDED THE LOG REVIEW INFORMATION TO CUSTOMER. CUSTOMER WANTED TO KNOW WHAT TO DO WITH THE SAMPLE WHICH RETESTED AS NEGATIVE. TS INFORMED CUSTOMER THAT THE PACKAGE INSERT DOES NOT PROVIDE GUIDANCE ON THIS AND WOULD BE UP TO THEIR MANAGEMENT AND SCIENTIFIC ADVISORS TO MAKE THAT DECISION. CUSTOMER RERAN THE SAMPLES. NO FURTHER ACTION IS REQUIRED FROM HOLOGIC.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THEY INADVERTENTLY DOUBLE ORDERED THE SARS-COV-2 TMA TESTS THAT WERE DONE ON THE PANTHER INSTRUMENT SN (B)(4). CUSTOMER DOUBLE ORDERED RACKS OF SAMPLES IN INSTEAD OF A SINGLE ORDER. THERE WERE TWO DISCREPANT RESULTS ON WL 000319-20220120-09 USING ASSAY LOT 315936.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4072 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 315936

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown