BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEPHEID XPERT MTB/RIF

    MDR report key: 20045223 · Received August 23, 2024

    Report

    Report Number
    3004530258-2024-00013
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    May 28, 2024
    Report Date
    October 1, 2024
    Manufacturer
    CEPHEID
    Product Code
    PEU
    UDI-DI
    07332940000912
    PMA / PMN Number
    DEN130032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    US CUSTOMER CONTACTED CEPHEID ON (B)(6) 2024 TO REPORT A QUESTIONABLE NEGATIVE RESULT USING XPERT MTB/RIF. COLLECTION 1: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS POSITIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 2: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 3: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 4: ON (B)(6) 2024 AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS WAS NOT IDENTIFIED FROM CULTURE. COLLECTION 5: ON (B)(6) 2024 AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS WAS NOT IDENTIFIED FROM CULTURE. CUSTOMER FOLLOWED KENT AND KUBICA METHOD FOR DECONTAMINATION AND CONCENTRATION. NALC/NAOH METHOD WAS USED AT A FINAL CONCENTRATION OF 1.5% OF NAOH. SAMPLES WERE REFRIGERATED PRIOR TO TESTING. CUSTOMER DOES NOT KNOW WHEN TREATMENT WAS STARTED. POSSIBLY AFTER MTB CULTURE REPORT, SAMPLES AT SOME POINT COLLECTED AFTER PATIENT STARTED TREATMENT AND IS OFF LABEL USE. CUSTOMER DIDN'T PERFORM ANY OTHER TESTS ON THE SAMPLES BESIDES AFB AND CULTURE. IN SECTION B1, B2 AND H1, WE HAVE CATAGORIZED THIS INCIDENT AS A SERIOUS INJURY AND ADVERSE EVENT, HOWEVER CEPHEID HAS NOT YET CONFIRMED THAT THERE WAS AN ADVERSE EVENT OR MALFUNCTION. CURRENTLY, THERE IS NO CONFIRMATION OF MALFUNCTION AND NO REPORT OF SERIOUS INJURY. HOWEVER, THE INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION REGARDING LIKELY ROOT CAUSE WILL BE PROVIDED IN A FOLLOW UP REPORT ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING PATIENT INFORMATION WAS PROVIDED FROM TB CONTROL TO CEPHEID. THE PATIENT IS A 51-YEAR-OLD MALE, BORN IN VIETNAM. PATIENT HAS CHRONIC HBV AND IS ON ENTECAVIR. PATIENT ALSO HAS HISTORY OF DIABETES MELLITUS AND HYPERLIPIDEMIA. THE PATIENT EXPERIENCED EXPOSURE TO HIS MOTHER WHO WAS INFECTIOUS WITH TB DISEASE. CXR HAD VERY SUBTLE ABNORMALITIES. POSITIVE SERUM QUANTIFERON GOLD. 3 SPUTA COLLECTED IN MAY AND ALL MTB/RIF NEGATIVE, ALL CULTURE POSITIVE, FIRST WAS 1+ SMEAR. TB THERAPY WAS NOT STARTED UNTIL (B)(6) 2024, WHEN FIRST MAY SPECIMEN WAS CULTURE POSITIVE. PER TB CONTROL, THIS LIKELY RESULTED IN EXPOSURE OF THE COMMUNITY TO INFECTIOUS TB WITH POSSIBLE TRANSMISSION. THE PATIENT REPORTED TO BE SYMPTOMATIC AND PER TB CONTROL, IT SEEMS UNLIKELY, AS FAR AS THEY CAN TELL, THAT SUFFERED MORBIDITY DUE TO THE SEVERAL-WEEK DELAY IN THE INITIATION OF TB CHEMOTHERAPY FOR ACTIVE PULMONARY TB DISEASE. THE CLINICIAN IS NOT AVAILABLE FOR DISCUSSION AND THE CLINICAL INFORMATION PROVIDED WAS BY THE PROGRAM DOCTOR AT LA COUNTY TB CONTROL. IN ATTEMPT TO PERFORM FURTHER ANALYSIS, WE WERE UNABLE TO RETRIEVE THE FILES FROM THE CUSTOMER. TO DATE, REVIEW OF CEPHEID'S COMPLAINT DATA AND INTERNAL CONTROL DATA FOR RELEASE OF THIS LOT SHOW NO INDICATION OF LOT OR SYSTEMIC MALFUNCTION. THE ROOT CAUSE IN THIS CASE IS INCONCLUSIVE. CURRENTLY, THERE IS NO CONFIRMATION OF MALFUNCTION AND NO REPORT OF SERIOUS INJURY. ADDITIONAL FOLLOW-UP: AT CEPHEID'S REQUEST, THE CUSTOMER TESTED TWO ISOLATES FROM THIS PATIENT, AND BOTH WERE MTB DETECTED, RIF RESISTANCE NOT DETECTED. THIS SUGGESTS THAT THE FALSE NEGATIVE RESULT WAS NOT DUE TO SOMETHING INTRINSIC TO THE STRAIN OF TB SUCH AS SEQUENCE DIVERSITY. SECTION H6 INVESTIGATION FINDINGS AND INVESTIGATIONS CONCLUSIONS, HEALTH EFFECT CLINICAL AND HEALTH EFFECT IMPACT CODES HAVE BEEN UPDATED TO REFLECT THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 0

    US CUSTOMER CONTACTED CEPHEID ON (B)(6) 2024 TO REPORT A QUESTIONABLE NEGATIVE RESULT USING XPERT MTB/RIF. COLLECTION 1: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS POSITIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 2: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 3: ON (B)(6) 2024, AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS IDENTIFIED FROM CULTURE. COLLECTION 4: ON (B)(6) 2024 AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS WAS NOT IDENTIFIED FROM CULTURE. COLLECTION 5: ON (B)(6) 2024 AN INDUCED SPUTUM SAMPLE WAS COLLECTED. SPUTUM SEDIMENT WAS TESTED PER PI ON XPERT MTB/RIF ON (B)(6) 2024, WHICH RESULTED IN MTB NOT DETECTED. THIS WAS REPORTED TO THE PHYSICIAN. AFB SMEAR WAS NEGATIVE. M. TUBERCULOSIS WAS NOT IDENTIFIED FROM CULTURE. CUSTOMER FOLLOWED KENT AND KUBICA METHOD FOR DECONTAMINATION AND CONCENTRATION. NALC/NAOH METHOD WAS USED AT A FINAL CONCENTRATION OF 1.5% OF NAOH. SAMPLES WERE REFRIGERATED PRIOR TO TESTING. CUSTOMER DOES NOT KNOW WHEN TREATMENT WAS STARTED. POSSIBLY AFTER MTB CULTURE REPORT, SAMPLES AT SOME POINT COLLECTED AFTER PATIENT STARTED TREATMENT AND IS OFF LABEL USE. CUSTOMER DIDN'T PERFORM ANY OTHER TESTS ON THE SAMPLES BESIDES AFB AND CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072130 CEPHEID XPERT MTB/RIF XPERT MTB/RIF ASSAY PEU CEPHEID 1001416984 07332940000912

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other