BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT MTB/RIF

    MDR report key: 7547062 · Received May 26, 2018

    Report

    Report Number
    3004530258-2018-00002
    Event Type
    Injury
    Date Received
    May 26, 2018
    Date of Event
    April 27, 2017
    Report Date
    May 25, 2018
    Manufacturer
    CEPHEID
    Product Code
    NQX
    PMA / PMN Number
    K143302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OR ALLEGATION FROM THE FIELD/CLINIC THAT THE DEVICE CONTRIBUTED TO THE INCIDENT. CEPHEID INVESTIGATION HAS DETERMINED THAT THIS IS NOT A DEVICE MALFUNCTION, PRODUCT IS ADEQUATELY LABELED AND THE PRODUCT HAS PERFORMED ACCORDING TO PRODUCT CLAIMS. CEPHEID HAS REQUESTED FOR ADDITIONAL INFORMATION WITH REGARDS TO THIS CASE (MULTIPLE ATTEMPTS MADE) AND HAS NOT RECEIVED ANY MORE INFORMATION.

    Description of Event or Problem · 1

    THE CLINICIAN (IN (B)(6) WERE THIS INCIDENT OCCURRED) RECEIVED A (B)(6) TEST WITH THE XPERT MTB/RIF THAT WAS LATER CONFIRMED AS INCORRECT VIA AN ALTERNATE METHODOLOGY. THE RESULT OF THE XPERT MTB/RIF WAS (B)(6) DETECTED VERY LOW AND (B)(6) DETECTED. THE PATIENT WAS SUBSEQUENTLY TREATED FOR THE CONDITION WITH SECOND LINE ANTIBIOTICS (TREATMENT REGIMEN UNKNOWN) WHICH MIGHT HAVE RESULTED IN KIDNEY FAILURE. THE CUSTOMER IN (B)(6) HAS NOT RESPONDED TO MULTIPLE ATTEMPTS FOR REQUEST OF ADDITIONAL INFORMATION AND IT IS NOT BELIEVED THAT THE MEDICAL EQUIPMENT MALFUNCTIONED. A REVIEW OF COMPLAINT DATA DOES NOT SHOW THAT THERE IS ANY TREND FOR THIS ISSUE. THIS EVENT HAPPENED IN (B)(6) (CE MARK PRODUCT) AND IT IS NOT BELIEVED THAT SUCH A SITUATION IS LIKELY TO OCCUR IN THE UNITED STATES (SUBSTANTIALLY EQUIVALENT PRODUCT SOLD IN THE UNITED STATES). THE PACKAGES INSERT LABELING CLEARLY STATES THAT RIF RESISTANCE NEEDS TO BE CONFIRMED BY A REFERENCE LABORATORY AND THE STANDARD OF CARE WILL PREVENT OCCURRENCE OF SUCH INCIDENTS (TOXICITY MONITORING ETC.) THE PACKAGE INSERT LIMITATION STATE: DUE TO THE LOW PREVALENCE OF RIFAMPIN RESISTANT TB IN THE UNITED STATES AND THE IMPLICATIONS OF RIFAMPIN RESISTANCE FOR TREATMENT, ALL MTB-COMPLEX STRAINS DETERMINED TO BE RIFAMPIN RESISTANT BY THE XPERT MTB/RIF ASSAY MUST HAVE THE PRESENCE OF RIFAMPIN RESISTANCE ASSOCIATED MUTATIONS OF THE RPOB GENE CONFIRMED BY A REFERENCE LABORATORY. ADDITIONAL TESTING FOR THE PRESENCE OF MUTATIONS ASSOCIATED WITH RESISTANCE TO OTHER DRUGS FOR THE TREATMENT OF TB SHOULD ALSO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389418 XPERT MTB/RIF GXMTB NQX CEPHEID GXMTB/RIF 1000062041

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening