BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA HPV ASSAY

    MDR report key: 13115392 · Received December 29, 2021

    Report

    Report Number
    2024800-2021-00083
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 29, 2021
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REQUESTED THE LOGS FROM THE CUSTOMER TO REVIEW. DUE TO THE INJECTION DELAY, THE CUSTOMER OBTAINED SEVERAL INVALID SAMPLES. IN ADDITION, THERE WAS A POTENTIAL FOR INCORRECT RESULTS WITH THE APTIMA HPV ASSAY. THERE IS NO INDICATION THAT THE ASSAY KITS WERE NOT PERFORMING AS EXPECTED. THE CUSTOMER WAS ADVISED BY HOLOGIC AND CUSTOMER RETESTED VALID POSITIVE SAMPLES AS POTENTIAL FALSE RESULTS WERE REPORTED OUT. IT'S NOT KNOWN IF TREATMENT WAS PROVIDED. HOLOGIC FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE, CONFIRMED THE ERRORS AND FOUND THAT THERE WERE FLUID BOTTLES NOT BE FULLY SEATED IN THE INSTRUMENT'S LOWER BAY, LIKELY INTRODUCING AIR TO THE SYSTEM AND CAUSING INJECTION ISSUES. FSE PROPERLY SEATED THE FLUID BOTTLES TO RESOLVE THE ISSUE. FSE EXPLAINED TO THE CUSTOMER THAT THE QUESTIONABLE TUBES RECEIVED ONLY AIR WHICH IS WHY THEY WERE INVALID.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A CUSTOMER FROM (B)(6) CALLED HOLOGIC TECHNICAL SUPPORT (TS) TO REPORT THAT THEY HAD SEVERAL INVALID RESULTS ON THE TIGRIS INSTRUMENT (SN (B)(4)) DUE TO P AND R FLAGS WHEN USING THE APTIMA HPV ASSAY MASTER LOT 307923. TS AND PRODUCT APPLICATION SPECIALISTS (PAS) REVIEWED THE KINETIC PROFILE AND OBSERVED THAT THE INVALID RESULTS MAY HAVE BEN CAUSED BY AUTO DETECT (AD) DELAY IN INJECTION. THE CUSTOMER INDICATED THAT ALL VALID RESULTS FROM THESE WORKLIST WERE REPORTED OUT. THE CUSTOMER WAS NOTIFIED BY HOLOGIC THAT POSITIVE RESULTS FROM THE FIRST TUBE MAY HAVE BEEN IMPACTED. THE CUSTOMER INDICATED THAT THEY RETESTED ANY POSITIVE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012987 APTIMA HPV ASSAY IN-VITRO DIAGNOSTIC OYB HOLOGIC INCORPORATED HPV Screening (250 Tests) - TIGRIS 307923 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown