BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-ST01 TEST KIT

    MDR report key: 6974547 · Received October 24, 2017

    Report

    Report Number
    1950204-2017-00349
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Report Date
    February 15, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K111909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECT INFORMATION FOR PMA/510(K) NUMBER IS K111909, NOT K111976.

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A FALSE SUSCEPTIBLE CLINDAMYCIN RESULT FOR FOUR (4) STREPTOCOCCUS PNEUMONIAE ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-ST01 TEST KIT (LOT 5400136243). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX'S REQUEST FOR ISOLATE SUBMITTAL. SUBMITTAL OF THE ISOLATE IS REQUIRED TO CONFIRM A VITEK 2 DISCREPANCY COMPARED TO THE REFERENCE METHOD. NO FURTHER INVESTIGATION IS POSSIBLE. VITEK® 2 AST-ST01 LOT # 5400136243 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A FALSE SUSCEPTIBLE CLINDAMYCIN RESULT FOR FOUR (4) STREPTOCOCCUS PNEUMONIAE ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-ST01 TEST KIT (LOT 5400136243). THE CUSTOMER REPORTED RECEIVING FALSE SUSCEPTIBLE CLINDAMYCIN RESULTS WITH THE AST-ST01 CARD, WHEN COMPARED TO THE DISK METHOD WHICH PRODUCED RESISTANT RESULTS. THE CUSTOMER OBTAINED THE SAME SUSCEPTIBLE RESULTS AFTER REPEAT TESTING. THE CUSTOMER STATED THE STRAINS DO NOT GROW WELL IN THE AST-ST01 CARD. THE CUSTOMER IS A GOVERNMENT REFERENCE LAB WHICH RECEIVES SAMPLES FOR CONFIRMATION TESTING. THE CUSTOMER STATED THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER STATED THERE IS NO POTENTIAL HARM TO PATIENTS AS THEY WILL DO OTHER CONFIRMATION TESTS. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753074 VITEK® 2 AST-ST01 TEST KIT VITEK® 2 AST-ST01 TEST CARD LON BIOMERIEUX, INC 5400136243

    Patients

    Seq Age Sex Outcome Treatment
    1