BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 7887234 · Received September 18, 2018

    Report

    Report Number
    2024800-2018-00009
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    August 27, 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 2024800-2018-00009 WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER AT (B)(6) REPORTED ON (B)(6) 2018 MULTIPLE INVALIDS ON THE TIGRIS PLATFORM, SN (B)(4). PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEW OF THE LOGS SHOWED A DELAY IN AUTO DETECT (AD) INJECTION. THERE WERE SEVEN SAMPLES POTENTIALLY IMPACTED DUE TO (B)(6) RESULTS. HOLOGIC ADVISED THE OPERATOR THAT THEY COULD REPORT VALID RESULTS; POTENTIAL FOR (B)(6) RESULTS HAD NOT BEEN COMMUNICATED TO THE CUSTOMER. ON 09/01/2018, HOLOGIC COMMUNICATED WITH THE CUSTOMER ASKING THEM TO REPEAT THE SAMPLES IN QUESTIONS AND MAKE NECESSARY CORRECTIONS TO ALREADY REPORTED RESULTS. THE CUSTOMER REPEATED TESTING ON (B)(6) 2018 AND MADE THE NECESSARY CORRECTIONS TO ALREADY REPORTED RESULTS. LOGS FROM (B)(6) 2018 WERE REQUESTED FOR FURTHER REVIEW. PER RISK ASSESSMENT, AS A RESULT OF THE AD INJECTION DELAY, TWO AC2 AND ONE (B)(6) ASSAYS FAILED. IN ADDITION, THE AD INJECTION DELAY LIKELY RESULTED IN (B)(6) RESULTS IN THE APTIMA (B)(6) ASSAY WHICH WERE LIKELY REPORTED TO THE RESPECTIVE PHYSICIANS. HOWEVER, HOLOGIC REQUESTED THE CUSTOMER TO RETEST THE SAMPLES IN QUESTION, WHICH WAS PERFORMED BY THE CUSTOMER. RETESTING SAMPLES IS A CUSTOMER INCONVENIENCE. IF THE (B)(6) 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. IT IS AN INCONVENIENCE FOR A PATIENT TO HAVE A COLPOSCOPY PERFORMED FOR A CYTOLOGY (B)(6) RESULT. THE SEVERITY ASSOCIATED WITH A (B)(6) RESULT USING THE APTIMA (B)(6) 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. THEREFORE, THE PROBABILITY OF THE PATIENT HAVING THE INCORRECT APTIMA (B)(6) ASSAY RESULTS IS REMOTE. THE FINAL RISK IS AS FAR AS POSSIBLE. FURTHER INVESTIGATION INTO THIS ISSUE IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728211 APTIMA HPV SCREENING ASSAY IN VITRO DIAGNOSTICS OYB HOLOGIC, INC. 240090 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O