BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    API® 20 STREP 25STRIPS

    MDR report key: 5156096 · Received October 16, 2015

    Report

    Report Number
    3002769706-2015-00118
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Report Date
    September 24, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JTO
    PMA / PMN Number
    CL I, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING INCLUDED 16S SEQUENCING AND API® STREP STRIP. 16S SEQUENCING CONFIRMED THE IDENTIFICATION OF ACTINOBACULUM SHAALII. API® STREP PROVIDED A LOW DISCRIMINATION IDENTIFICATION OF GARDNERELLA VAGINALIS / AERCOCCUS URINAE. THE SPECIES ACTINOBACULUM SCHAALII IS NOT IN THE KNOWLEDGE BASE OF API® STREP; THEREFORE IDENTIFICATION TO THE EXPECTED RESULT WAS NOT POSSIBLE. AS THE API® 20 STREP SYSTEM IS DESIGNED UNIQUELY FOR THE IDENTIFICATION OF THE SPECIES INCLUDED IN THE DATABASE, IT CANNOT BE USED TO IDENTIFY ANY OTHER MICROORGANISMS OR TO EXCLUDE THEIR PRESENCE. THE API® STREP PRODUCT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2015 A CUSTOMER CALLED TO REPORT A MIS-IDENTIFICATION WHEN USING PRODUCT API CORYNE STRIPS REPORTED ON IN (B)(4). CUSTOMER RETESTED SPECIMEN USING API STREPTO (B)(4), LOT 1003578000 (AEROCOCCUS UREALITICUM) WHICH PROVIDED INCORRECT RESULTS, EXPECTED RESULTS SHOULD HAVE BEEN ACTINOBACULUM SCHAALII. CUSTOMER USED TWO DIFFERENT API STRIPS TO TEST THIS CNQ (API CORYNE AND API STREPTO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686104 API® 20 STREP 25STRIPS API® 20 STREP 25STRIPS JTO BIOMERIEUX SA 1003578000

    Patients

    Seq Age Sex Outcome Treatment
    1