BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 8804040 · Received July 18, 2019

    Report

    Report Number
    2024800-2019-00008
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 19, 2019
    Report Date
    September 25, 2019
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K132251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A RISK ASSESSMENT WAS PERFORMED BY HOLOGIC WHERE IT WAS DETERMINED THE PROBABILITY DUE TO HARM IS REMOTE DUE TO THE VERY LOW PREVALENCE (N=1) AND THE HIGH NUMBER OF SAMPLES TESTED. TESTING OF IN VITRO TRANSCRIPTS (IVTS) CONTAINING THE MUTATION DEMONSTRATED THAT IT CAN IMPACT AC2 ASSAY PERFORMANCE. THEREFORE, IT IS POSSIBLE THAT CT VARIANTS THAT CONTAIN A NOVEL MUTATION IN THE AC2 PROBE REGION COULD IMPACT AC2 ASSAY PERFORMANCE. A COMPLAINT TRENDING ANALYSIS FOR THE PAST 3 YEARS DID NOT SHOW AN INCREASE IN INCORRECT RESULTS. ADDITIONALLY, THERE HAVE BEEN SEVERAL RECENT PUBLICATIONS HAVE DEMONSTRATED COMPARABLE PERFORMANCE OF THE AC2 ASSAY WITH OTHER MANUFACTURERS' ASSAYS INDICATING THAT ASSAY PERFORMANCE IS IN ALIGNMENT WITH THE ORIGINAL PERFORMANCE OF THE ASSAY.1-5 1. DIZE L, ET AL. COMPARISON OF THE CEPHEID GENEXPERT CT/NG ASSAY TO THE HOLOGIC APTIMA COMBO 2 ASSAY FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE IN SELF-COLLECTED RECTAL SWABS. DIAGN MICROBIOL INFECT DIS. 2018; 90(2): 83-84. DOI: 10.1016/J.DIAGMICROBIO.2017.10.013. 2. GEIGER R, ET AL. VALIDATION OF THE GENEXPERT® CT/NG ASSAY FOR USE WITH MALE PHARYNGEAL AND RECTAL SWABS. AUSTIN J HIV AIDS RES. 2016; 3(1): PII: 1021. 3. NYE MB, ET AL. DETECTION OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE WITH THE COBAS CT/NG V2.0 TEST: PERFORMANCE COMPARED WITH THE BD PROBETEC CT QX AND GC QX AMPLIFIED DNA AND APTIMA AC2 ASSAYS. SEX TRANSM INFECT. 2019; 95(2): 87-93. DOI: 10.1136/SEXTRANS-2018-053545. 4. VAN DER POL B, ET AL. EVALUATION OF THE PERFORMANCE OF THE COBAS CT/NG TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS FOR DETECTION OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE IN MALE AND FEMALE UROGENITAL SAMPLES. J CLIN MICROBIOL. 2019; 57(4): PII: E01996-18. DOI: 10.1128/JCM.01996-18. 5. VENTER JME, ET AL. COMPARISON OF AN IN-HOUSE REAL-TIME DUPLEX PCR ASSAY WITH COMMERCIAL HOLOGIC® APTIMA ASSAYS FOR THE DETECTION OF NEISSERIA GONORRHOEAE AND CHLAMYDIA TRACHOMATIS IN URINE AND EXTRA-GENITAL SPECIMENS. BMC INFECT DIS. 2019; 19(1): 6. DOI: 10.1186/S12879-018-3629-0.

    Description of Event or Problem · 0

    SEE SECTION 10 FOR FINAL RESULTS.

    Description of Event or Problem · 1

    CUSTOMER, (B)(6), REPORTED ONE UNIQUE PATIENT IN WHICH THE PHYSICIAN SENT SAMPLES OVER A 3-MONTH PERIOD: ON (B)(6) 2019: TESTED TWICE ON AC2 WITH ONE EQUIVOCAL CHLAMYDIA RESULT AND ONE NEGATIVE CHLAMYDIA RESULT. REPORTED EQUIVOCAL TO PHYSICIAN. ON (B)(6) 2019: TESTED TWICE USING AC2, BOTH REPORTING EQUIVOCAL CHLAMYDIA RESULTS. REPORTED EQUIVOCAL TO PHYSICIAN ON (B)(6) 2019: TEST TWICE ON AC2 WITH, BOTH REPORTING EQUIVOCAL CHLAMYDIA RESULT. TESTED SAMPLE WITH APTIMA CHLAMYDIA (ACT ON TIGRIS) WITH A RESULT OF POSITIVE. REPORTED POSITIVE CT RESULT TO PHYSICIAN. THE SWAB SPECIMEN FROM (B)(6) 2019 SAMPLES WAS SENT TO HOLOGIC AND SEQUENCED. A SINGLE BASE CHANGE WAS OBSERVED COMPARED TO PUBLISHED C. TRACHOMATIS 23S RRNA (WILD TYPE) SEQUENCES. A RISK ASSESSMENT IS IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597186 APTIMA COMBO 2 ASSAY IN-VITRO DIAGNOSTIC LSL HOLOGIC, INC. 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other