BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS COV-2

    MDR report key: 15126523 · Received July 28, 2022

    Report

    Report Number
    2024800-2022-01074
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 2, 2022
    Report Date
    July 28, 2022
    Manufacturer
    HOLOGIC, INC.
    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 INSTRUMENT OR ASSAY PERFORMANCE ISSUES. TS MADE GOOD FAITH EFFORTS TO FOLLOW UP WITH CUSTOMER BUT WAS NOT ABLE TO ACQUIRE ADDITIONAL INFORMATION FROM THEM, SUCH AS FOR THE SAMPLE IDS, WLS AND LOGS FOR THE OTHER PANTHER SAMPLES WERE RUN ON. HOLOGIC FIELD APPLICATIONS SPECIALIST (FAS) INFORMED CUSTOMER THAT LOW-TARGET SAMPLES MAY NOT REPEAT WHEN RETESTED AND CONFIRMED WITH THEM THAT THEY HAD NO FURTHER ISSUES REPORTED. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL APTIMA SARS-COV-2 ASSAY QUESTIONING RESULTS AND FALSE RESULTS (CONFIRMED OR NOT) COMPLAINTS TO BE REPORTED AS MALFUNCTION MDR.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE SARS-COV-2 TMA RUN, WL 002658-20220527-04, USING ASSAY LOT: 320191 ON PANTHER PLUS INSTRUMENT SN: (B)(4) WHICH HAD 7 DISCREPANT SAMPLES. CUSTOMER RAN THE ORIGINAL SAMPLES ON ANOTHER PANTHER WHERE THEY RESULTED POSITIVE BUT WERE NEGATIVE IN THE WL IN QUESTION. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. THERE WAS NO INDICATION OF RESULTS BEINGS REPORTED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344063 APTIMA SARS COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC, INC. 320191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown