BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT XPRESS GBS

    MDR report key: 19697359 · Received July 8, 2024

    Report

    Report Number
    3004530258-2024-00010
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    May 30, 2024
    Report Date
    July 8, 2024
    Manufacturer
    CEPHEID AB
    Product Code
    NJR
    PMA / PMN Number
    K222638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024 A CUSTOMER FROM ULSTMAD VILA REAL REPORTED A QUESTIONABLE NEGATIVE RESULT ON XPERT XPRESS GBS (GROUP B STREPTOCOCCUS). ON (B)(6) 2024, A PREGNANT WOMAN AT 37 WEEKS AND 2 DAYS, UNDERGOING HER FIRST PREGNANCY WITH NO HISTORY OF GBS INFECTION AND COLONIZATION, DURING A ROUTINE PRENATAL SCREENING WAS TESTED WITH XPERT XPRESS GBS USING A DOUBLE VAGINAL/RECTAL SWAB. THE TEST RESULT REPORTED: NEGATIVE. ON (B)(6) 2024, AT 39 WEEKS AND 4 DAYS, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHILDBIRTH. HOWEVER, DURING THE CHILDBIRTH, THE PATIENT DEVELOPED A FEVER (38°C) BUT NO TREATMENT WAS ADMINISTERED AND NO SAMPLE WAS COLLECTED. THE NEWBORN WAS MONITORED FOR SUBSEQUENT SEPSIS AND WAS DIAGNOSED WITH MENINGITIS AND SEPSIS CAUSED BY STREPTOCOCCUS AGALACTIAE. THE CUSTOMER CONFIRMED THAT THE TEST WAS CONDUCTED CORRECTLY BY TRAINED PERSONNEL FOLLOWING CEPHEID'S RECOMMENDATIONS. ON (B)(6) 2024, DUE TO CHANGES IN BEHAVIOR, BLOOD SAMPLES WERE COLLECTED FROM THE BABY, INCLUDING PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP). PCT AND CRP LEVELS WERE INCREASED (50.6 NG/ML AND 11.33 MG/L, RESPECTIVELY) AND ANTIMICROBIAL THERAPY WAS INITIATED AFTER BLOOD CULTURES WERE COLLECTED. THE THERAPY CONSISTED OF AMOXICILLIN, CEFTRIAXONE, AND GENTAMICIN. BLOOD CULTURES WERE POSITIVE FOR GBS AND NO ADDITIONAL SAMPLES WERE COLLECTED FROM THE MOTHER. ON (B)(6) 2024, THE BABY WAS TRANSFERRED TO AN ACADEMIC HOSPITAL FOR NEONATAL SUPPORT. CEREBROSPINAL FLUID (CSF) WAS COLLECTED AFTER STARTING ANTIMICROBIAL THERAPY SHOWED POSITIVE GRAM-POSITIVE COCCI BUT REMAINED STERILE. ON (B)(6) 2024, THE BABY RETURNED TO THE ULSTMAD HOSPITAL AND GENTAMICIN WAS DISCONTINUED AFTER 5 DAYS, FOLLOWED BY CEFTRIAXONE AFTER 7 DAYS. AMOXICILLIN WAS PRESCRIBED FOR 14 DAYS. ON (B)(6)2024, THE BABY WAS DISCHARGED HOME WITHOUT FURTHER COMPLICATIONS WITH A DIAGNOSIS OF EARLY ONSET GROUP B STREPTOCOCCAL (EOGBS) DISEASE. BASED ON THE SUMMARY OF THE INVESTIGATION RESULTS, NO FIRM CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ASCERTAINED AS NO SAMPLES OR CULTURES HAVE BEEN PROVIDED. HOWEVER, CEPHEID DETERMINED THAT THE ROOT CAUSE COULD BE RELATED TO THE INTERMITTENT GROUP B STREPTOCOCCUS (GBS) CARRIAGE. THE PROBABILITY OF MUTATION HAS BEEN EXCLUDED AS THE XPERT XPRESS GBS TEST UTILIZES DUAL GBS TARGETS. IN CONCLUSION, THE COMPLAINT REMAINS REPORTABLE. THE BABY WAS DISCHARGED HOME WITHOUT FURTHER COMPLICATIONS WITH A DIAGNOSIS OF EARLY ONSET GROUP B STREPTOCOCCAL (EOGBS) DISEASE. NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT XPRESS GBS TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.

    Description of Event or Problem · 0

    ON (B)(6) 2024 A CUSTOMER FROM ULSTMAD VILA REAL REPORTED A QUESTIONABLE NEGATIVE RESULT ON XPERT XPRESS GBS (GROUP B STREPTOCOCCUS). ON (B)(6) 2024, A PREGNANT WOMAN AT 37 WEEKS AND 2 DAYS, UNDERGOING HER FIRST PREGNANCY WITH NO HISTORY OF GBS INFECTION AND COLONIZATION, DURING A ROUTINE PRENATAL SCREENING WAS TESTED WITH XPERT XPRESS GBS USING A DOUBLE VAGINAL/RECTAL SWAB. THE TEST RESULT REPORTED: NEGATIVE. ON (B)(6) 2024, AT 39 WEEKS AND 4 DAYS, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHILDBIRTH. HOWEVER, DURING THE CHILDBIRTH, THE PATIENT DEVELOPED A FEVER (38°C) BUT NO TREATMENT WAS ADMINISTERED AND NO SAMPLE WAS COLLECTED. THE NEWBORN WAS MONITORED FOR SUBSEQUENT SEPSIS AND WAS DIAGNOSED WITH MENINGITIS AND SEPSIS CAUSED BY STREPTOCOCCUS AGALACTIAE. THE CUSTOMER CONFIRMED THAT THE TEST WAS CONDUCTED CORRECTLY BY TRAINED PERSONNEL FOLLOWING CEPHEID'S RECOMMENDATIONS. ON (B)(6) 2024, DUE TO CHANGES IN BEHAVIOR, BLOOD SAMPLES WERE COLLECTED FROM THE BABY, INCLUDING PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP). PCT AND CRP LEVELS WERE INCREASED (50.6 NG/ML AND 11.33 MG/L, RESPECTIVELY) AND ANTIMICROBIAL THERAPY WAS INITIATED AFTER BLOOD CULTURES WERE COLLECTED. THE THERAPY CONSISTED OF AMOXICILLIN, CEFTRIAXONE, AND GENTAMICIN. BLOOD CULTURES WERE POSITIVE FOR GBS AND NO ADDITIONAL SAMPLES WERE COLLECTED FROM THE MOTHER. ON (B)(6) 2024, THE BABY WAS TRANSFERRED TO AN ACADEMIC HOSPITAL FOR NEONATAL SUPPORT. CEREBROSPINAL FLUID (CSF) WAS COLLECTED AFTER STARTING ANTIMICROBIAL THERAPY SHOWED POSITIVE GRAM-POSITIVE COCCI BUT REMAINED STERILE. ON (B)(6) 2024, THE BABY RETURNED TO THE ULSTMAD HOSPITAL AND GENTAMICIN WAS DISCONTINUED AFTER 5 DAYS, FOLLOWED BY CEFTRIAXONE AFTER 7 DAYS. AMOXICILLIN WAS PRESCRIBED FOR 14 DAYS. ON (B)(6) 2024, THE BABY WAS DISCHARGED HOME WITHOUT FURTHER COMPLICATIONS WITH A DIAGNOSIS OF EARLY ONSET GROUP B STREPTOCOCCAL (EOGBS) DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152102 XPERT XPRESS GBS XPERT XPRESS GBS NJR CEPHEID AB 1000923555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O