BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 7864644 · Received September 11, 2018

    Report

    Report Number
    2024800-2018-00008
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    August 14, 2018
    Report Date
    February 13, 2019
    Manufacturer
    HOLOGIC, INC
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL INVESTIGATION RESULTS: HOLOGIC PERFORMED AN INVESTIGATION TO DETERMINE THE ROOT CAUSE FOR THE POTENTIAL FALSE POSITIVE HPV RESULTS USING THE APTIMA HPV ASSAY. BRIEFLY, THE INVESTIGATION CONCLUDED THAT THE POTENTIAL FALSE POSITIVE HPV RESULTS WERE CAUSED BY AIR BUBBLES THAT ENTERED THE AUTO DETECT INJECTION LINE PRIOR TO WHEN THE TIGRIS PROCESSED THE FIRST SAMPLE OF AN MTU. THE APTIMA HPV ASSAY PRODUCES TWO DIFFERENT RLU SIGNAL TYPES: 1) THE INTERNAL CONTROL-SPECIFIC AMPLICON, WHICH IS DETECTED USING A PROBE WITH A RAPID EMISSION OF LIGHT (FLASHER) AND 2) THE HPV SPECIFIC AMPLICON, WHICH IS DETECTED USING PROBES WITH RELATIVELY SLOWER KINETICS OF LIGHT EMISSION (GLOWER). AN AIR BUBBLE WOULD DELAY THE AUTO DETECT REAGENTS FROM REACHING THE SAMPLE TUBE WHEN THE INSTRUMENT LUMINOMETER INITIATES RLU READS. THIS DELAY IN RLU RESPONSE SHIFTED THE INTERNAL CONTROL-SPECIFIC FLASHER SIGNAL TO APPEAR IN THE GLOWER SIGNAL RANGE, POTENTIALLY PRODUCING A LOW POSITIVE HPV RESULT. GENERALLY, AIR BUBBLES IN THE LINES ARE APPARENT BASED ON THE CALIBRATORS AND CONTROLS INVALIDATING ASSAY RUNS. THEREFORE, IF A CUSTOMER CONTACTS HOLOGIC, THE RISK OF REPORTING POTENTIAL FALSE POSITIVE HPV RESULTS BY THAT PARTICULAR CUSTOMER MAY BE MITIGATED. A FIELD SERVICE ENGINEER WAS SENT TO THE SITE AND EITHER CLEANED OR REPLACED THE AUTO DETECT 2 SYRINGE, WHICH ELIMINATED THE AIR BUBBLE FORMING IN THE INJECTION LINES. PER RISK ASSESSMENT, THE SEVERITY ASSOCIATED WITH A FALSE POSITIVE RESULT USING THE APTIMA HPV ASSAY IS SERIOUS. TO MITIGATE THIS RISK, HOLOGIC REQUESTED THE CUSTOMER TO RETEST THE SAMPLES IN QUESTION; THE CUSTOMER RETESTED THE SAMPLES AND MADE THE NECESSARY CORRECTED REPORTS ADDITIONALLY, THE FREQUENCY OF AN AIR BUBBLE CAUSING INCORRECT RESULTS IS REMOTE OCCURRENCE

    Description of Event or Problem · 0

    THIS IS THE FINAL REPORT FOR 2024800-2018-00008 WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER AT LABCORP'S (B)(4) SITE REPORTED ((B)(4)) THREE (3) FAILED RUNS ON THEIR TIGRIS INSTRUMENT, SN (B)(4). TECHNICAL SERVICE (TS) REVIEWED TIGRIS LOGS AND FOUND TWO (2) APTIMA COMBO 2 (AC2) RUNS AND 1 APTIMA TRICHOMONAS VAGINALIS (ATV) RUN THAT HAD FAILED DUE TO AUTO DETECT (AD) INJECTION DELAYS. HOLOGIC RECOMMENDED THE CUSTOMER REPLACE AUTO DETECT BOTTLE CAPS. THE CUSTOMER CALLED IN AGAIN ON THE 8-20-18 (00367099) REPORTING ADDITIONAL RUN FAILURES ON AC2 AND ATV. A FIELD SERVICE ENGINEER WAS REQUESTED TO GO INTO THE LABORATORY AND SERVICE THE INSTRUMENT. TO FURTHER ASSESS THE ISSUE, A HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED TIGRIS LOGS (SN (B)(4)) FROM 08/07/2018 - 08/20/2018 FOR ALL ASSAY RUN ON THAT TIGRIS SYSTEM. FROM THAT REVIEW, IT WAS DETERMINED THAT A SUBSET OF SAMPLES FROM THE CUSTOMER'S APTIMA HPV ASSAY RUNS MAY HAVE ALSO BEEN AFFECTED BY THE AUTO DETECT DELAY IN INJECTION. HOLOGIC NOTIFIED THE CUSTOMER AND ADVISED THE CUSTOMER TO RETEST THE SAMPLES. ON 9-4-2018, HOLOGIC FIELD APPLICATION SPECIALIST (FAS) SPOKE WITH THE HPV MANAGER AT THE (B)(4) LABORATORY WHO CONFIRMED THAT THE LABORATORY RE-RAN THE SAMPLES AND THE CORRECTED RESULTS WERE SENT TO PHYSICIANS. THERE WERE NO INCORRECT RESULTS ASSOCIATED WITH AC2 OR ATV SAMPLES, AS THESE ASSAYS WERE INVALIDATED DUE TO ERRORS CAUSED BY THE INJECTION DELAY. HOWEVER, THE AD INJECTION DELAY LIKELY RESULTED IN FALSE POSITIVE RESULTS IN THE APTIMA HPV ASSAY WHICH WERE REPORTED TO THE RESPECTIVE PHYSICIANS. THE SEVERITY ASSOCIATED WITH A FALSE POSITIVE RESULT USING THE APTIMA HPV ASSAY IS [?]SERIOUS'. TO MITIGATE THIS RISK, HOLOGIC REQUESTED THE CUSTOMER TO RETEST THE SAMPLES IN QUESTION; THE CUSTOMER RETESTED THE SAMPLES AND MADE THE NECESSARY CORRECTED REPORTS. HOLOGIC SENT IN A FIELD SERVICE ENGINEER TO CONFIRM THE INSTRUMENT IS PERFORMING AS EXPECTED AND THAT THERE WERE NO FURTHER INJECTION DELAY ISSUES. FURTHER INVESTIGATION INTO THIS ISSUE IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706073 APTIMA HPV SCREENING ASSAY IN-VITRO DIAGNOSTIC OYB HOLOGIC, INC 239642, 240090 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other