BEUDAMED
    FDA Adverse Event Summary report: N

    ACCUPROBE GROUP B STREP TEST

    MDR report key: 3680237 · Received March 14, 2014

    Report

    Report Number
    2024800-2014-00002
    Date Received
    March 14, 2014
    Date of Event
    January 7, 2014
    Report Date
    March 14, 2014
    Manufacturer
    GEN-PROBE INCORPORATED
    Product Code
    MDK
    PMA / PMN Number
    K974572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION NOT REQUIRED. USER ERROR.

    Description of Event or Problem · 1

    THE TECHNICIAN AT (B)(6) REPORTED TESTING WITH THE KIT, BULK, GROUP B STREP, ACCUPROBE (MN: (B)(4) BN: (B)(4)) AND INCORRECTLY USED THE REAGENTS. THREE SAMPLES WHICH WERE ORIGINALLY NEGATIVE WERE POSITIVE USING THE CORRECT REAGENTS. ALTHOUGH THERE WAS CORRECTION OF THE REPORTED RESULTS, THERE EXISTED THE POTENTIAL FOR FALSE NEGATIVE TEST RESULTS AND THE POTENTIAL FOR DELAY IN TREATMENT OF TRUE POSITIVE TEST RESULTS. THIS NOT A DEVICE ERROR OR A FAILURE WITH THE PRODUCT, BUT RATHER AN OPERATOR ERROR BASED ON IMPROPER USE OF THE REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154570 ACCUPROBE GROUP B STREP TEST GROUP B STREP MDK GEN-PROBE INCORPORATED 633429

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR