BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA HPV ASSAY

    MDR report key: 12873051 · Received November 24, 2021

    Report

    Report Number
    2024800-2021-00012
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 28, 2021
    Report Date
    November 24, 2021
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON THE SITE AND CONCLUDED THAT A POSSIBLE AN AIR BUBBLE CAUSED AN INJECTION DELAY. FSE REPLACED THE AD2 IPV (SYRINGE AND VALVE, IPV) TO RESOLVE THE PROBLEM. THE SYSTEM WAS WORKING AS INTENDED AFTER THE REPAIR. RISK ASSESSMENT WAS PERFORMED AND DETERMINED THAT IF THE PATIENT RECEIVED A FALSE POSITIVE RESULT FOR HPV, THE POTENTIAL IMPACT TO THE PATIENT WOULD BE INCONVENIENCE, ANXIETY, AND OVER-TESTING. OF NOTE, THERE IS NO REPORT OF PATIENT ANXIETY/IMPACT BECAUSE OF THIS ISSUE. IF THE FALSE POSITIVE RESULT WAS OBTAINED DURING REPEAT CO-TESTING, A COLPOSCOPY IS RECOMMENDED. A COLPOSCOPY IS AN INVASIVE PROCEDURE THAT ALLOWS THE HEALTH CARE PROVIDER TO LOOK AT THE CERVIX THROUGH A MAGNIFYING DEVICE; A BIOPSY MAY BE PERFORMED IF THE HEALTH CARE PROVIDER SEES ABNORMAL AREAS. THE PATIENT IMPACT OF HAVING A COLPOSCOPY PERFORMED FOR A CYTOLOGY (B)(6) IS DISCOMFORT AND INCONVENIENCE.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED HOLOGIC TO REPORT A VALID APTIMA HPV RUN (LOT 303949) THAT CONTAINED HIGH BACKGROUND (HB) FLAGS ON ONE POSITIVE CALIBRATOR AND ONE NEGATIVE CALIBRATOR REPLICATE ON TIGRIS SN (B)(4). CUSTOMER REQUESTED FOR HOLOGIC TO REVIEW THEIR LOGS. PRODUCT APPLICATION SPECIALIST (PAS) REVIEWED CUSTOMER DATA FROM (B)(4) AND NOTED 2 SAMPLES THAT WERE REPORTED OUT WERE IMPACTED BY A DELAY IN AUTO DETECT (AD) INJECTION. CUSTOMER CONFIRMED THAT THE 2 SAMPLES WERE RETESTED (INITIAL POSITIVE, RETEST NEGATIVE) AND THE REPORTED RESULTS WERE AMENDED. NO INJURY WAS REPORTED DURING THIS EVENT. CUSTOMER REPORTED IT WAS UNKNOWN IF TREATMENT WERE PROVIDED TO THE IMPACTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770142 APTIMA HPV ASSAY IN-VITRO DIAGNOSTIC OYB HOLOGIC INCORPORATED HPV Screening (250 Tests) - TIGRIS 303949 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown