BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT XPRESS FLU/RSV (CE)

    MDR report key: 19780097 · Received July 18, 2024

    Report

    Report Number
    3004530258-2024-00011
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    May 30, 2024
    Report Date
    September 6, 2024
    Manufacturer
    CEPHEID
    Product Code
    OCC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRAZIL CUSTOMER CONTACTED CEPHEID ON (B)(6) 2024 TO DISCUSS A DISCREPANT RESULT OF A XPERT XPRESS FLU-RSV TEST. PATIENT WAS BORN ON (B)(6) 2024. THE SAMPLE WAS COLLECTED AND TESTED ON (B)(6) 2024 AND RAN XPERT XPRESS FLU-RSV WHICH RESULTED IN NEGATIVE FOR FLU A, FLU B AND RSV. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2024 AND SENT TO ANOTHER LAB WITH POSITIVE RESULT FOR RSV. REPORT NOT PROVIDED TO CEPHEID. CEPHEID ATTEMPTED TO REACH OUT TO THE CUSTOMER THROUGH EMAIL ON 20-JUN-2024 AND BY PHONE 19-JUN-2024, 21-JUN-2024 AND 24-JUN-2024. CUSTOMER STATED SAMPLE COLLECTED WAS A NASAL SWAB IN VTM. SAMPLE WAS PROCESSED AND COLLECTED ON (B)(6) 2024, PROCESSED IMMEDIATELY UPON RECEIPT AT THE LABORATORY. CUSTOMER DOESN'T HAVE ACCESS TO THE INFORMATION REGARDING OTHER PLATFORM THE DISCREPANT TEST WAS PERFORMED ON AND HAS NO DATA. REPEAT TESTING WAS PERFORMED ON DIFFERENT SAMPLES. SAMPLE SENT TO OTHER LAB WAS COLLECTED ON (B)(6) 2024 AND SENT TO OTHER LAB ON THE SAME DAY, REPORT CONFIRMS DATE OF RECEIPT ON (B)(6) 2024. TEST RELEASED ON 03-JUN-2024, WITH NO INFORMATION ON THE CONDITIONS UNDER WHICH THIS SAMPLE WAS SENT AND STORED AT OTHER LAB. THE XPRESS FLU/RSV RESULT WAS REPORTED TO THE PHYSICIAN. THE DOCTOR CONSULTED THE PATIENT'S REPORT AND CHECKED ALL THE UNDETECTED RESULTS, SO THE PATIENT WAS NOT SENT TO AN ISOLATION BED. PATIENT IN ICU BED TREATED FOR ACUTE VIRAL BRONCHIOLITIS, FURTHER TESTS WERE REQUESTED TO INVESTIGATE THE ETIOLOGIC AGENT. PATIENT AGE WAS 2 MONTHS AND PRESENTED WITH CLINICAL CONDITION OF ACUTE VIRAL BRONCHIOLITIS. PATIENT STARTED SHOWING SYMPTOMS ON MAY 21, CAME TO THE EMERGENCY ROOM WITH A COUGH AND NASAL CONGESTION. NEBULIZATION WITH CLENIL WAS STARTED. PATIENT RETURNED ON (B)(6) 2024 CUSTOMER STATING "LAST WEEK HE WAS IN THE SERVICE, HE HAD SECRETIONS IN HIS AIRWAYS, HE WAS TREATED WITH CLENIL FOR 5 DAYS. YESTERDAY SHE STARTED HAVING SECRETIONS IN HER EYES AND AIRWAYS, AND HAD A PRODUCTIVE COUGH, SOMETIMES CHOKING ON HER COUGH. DIFFICULTY SUCKLING. NO FEVER. SHE CONSULTED HER PEDIATRICIAN ONLINE, WHO ASKED HER TO COME TO THE ER. HAS A 4-YEAR-OLD BROTHER WHO ATTENDS NURSERY SCHOOL. MOTHER HAS ASTHMA." DISCHARGED WITH PRESCRIPTION AFTER X-RAY AND IMPROVEMENT IN SYMPTOMS. PATIENT RETURNED TO THE ER ON (B)(6) 2024 CUSTOMER STATING "MOTHER HAS BEEN REPORTING FLU-LIKE SYMPTOMS FOR A WEEK, WORSENING THIS MORNING. TODAY SHE STARTED WITH A FEVER. NORMAL URINE AND STOOLS. NO VOMITING. DIFFICULTY BREASTFEEDING. CONTACT WITH 4-YEAR-OLD BROTHER WHO ATTENDS NURSERY SCHOOL. HE TOOK CLENIL A AND SALBUTAMOL, WITH NO IMPROVEMENT." ON THE SAME DAY, (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE ICU AND IS STILL HOSPITALIZED TODAY. CUSTOMER STATED PATIENT WAS IN A SHARED ROOM BUT NOT WITH ANOTHER RSV-POSITIVE CHILD. CLENIL IS THE ONLY PRESCRIPTION THE PATIENT USED. THE CHILD WAS ADMITTED TO THE ICU ON (B)(6) 2024. REVIEW OF THE INITIAL XPRESS FLU/RSV TEST RESULTS SHOWS NO TARGETS DETECTED. THE INTERNAL CONTROL WAS DETECTED HOWEVER THE SINGLE IS DELAYED AND SOMEWHAT WEAK, WITH AN ODD SHAPE. A FEW OPTIONS FOR LIKELY ROOT CAUSE OR AVAILABLE, SUCH AS INADEQUATE SAMPLE COLLECTION OR PROCESSING, DIFFERENCES IN SAMPLE COLLECTION (I.E. SAMPLE BIAS) BETWEEN THE TWO SAMPLES AND/OR PRESENCE OF AN INHIBITOR IN LOW CONCENTRATION. PATIENT APPEARS TO HAVE BEEN TREATED WITH CLENIL IN THE DAYS PRIOR TO TESTING. THIS DRUG HAS NOT BEEN TESTED FOR INTERFERENCE ON THE PRODUCT IFU. FOR A SAMPLE WITH RSV TARGET AT OR BELOW THE LIMIT OF DETECTION FOR THE TEST, THESE FACTORS COULD CONTRIBUTE TO A FALSE-NEGATIVE RESULT. IT IS ALSO POSSIBLE THAT THE PATIENT'S VIRAL LOAD INCREASED BETWEEN THE ORIGINAL TEST ON (B)(6) 2024 AND THE SECTION SAMPLE ACQUISITION ON (B)(6) 2024. AS SUCH, THIS SECOND SAME MAY HAVE CONTAINED A DETECTABLE QUANTITY OF GENETIC MATERIAL, WHEREAS THE FIRST SAMPLE DID NOT. PATIENT APPEARS TO HAVE RECEIVED APPROPRIATE TREATMENT FOR ACUTE BRONCHITIS REGARDLESS OF DEFINITIVE RSV STATUS. HOWEVER, GIVEN THE ON-LABEL USE OF THIS TEST, THE CONTINUED ILLNESS OF THE ORIGINAL PATIENT, AND THE RISK OF SECONDARY EXPOSURE TO OTHER PATIENTS. AS OF (B)(6) 2024, THE CHILD IS STILL SICK. THE INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION REGARDING LIKELY ROOT CAUSE WILL BE PROVIDED IN A FOLLOW UP REPORT ONCE THE INVESTIGATION HAS BEEN COMPLETED. A CORRECTION HAS BEEN MADE TO SECTION B5 AND H11. THE CUSTOMER THAT CONTACTED CEPHEID WAS FROM BRAZIL, NOT US. 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

    US CUSTOMER CONTACTED CEPHEID ON 18-JUN-2024 TO DISCUSS A DISCREPANT RESULT OF A XPERT XPRESS FLU-RSV TEST. PATIENT WAS BORN ON (B)(6) 2024. THE SAMPLE WAS COLLECTED AND TESTED ON (B)(6) 2024 AND RAN XPERT XPRESS FLU-RSV WHICH RESULTED IN NEGATIVE FOR FLU A, FLU B AND RSV. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2024 AND SENT TO ANOTHER LAB WITH POSITIVE RESULT FOR RSV. REPORT NOT PROVIDED TO CEPHEID. CEPHEID ATTEMPTED TO REACH OUT TO THE CUSTOMER THROUGH EMAIL ON 20-JUN-2024 AND BY PHONE 19-JUN-2024, 21-JUN-2024 AND 24-JUN-2024. CUSTOMER STATED SAMPLE COLLECTED WAS A NASAL SWAB IN VTM. SAMPLE WAS PROCESSED AND COLLECTED ON (B)(6) 2024, PROCESSED IMMEDIATELY UPON RECEIPT AT THE LABORATORY. CUSTOMER DOESN'T HAVE ACCESS TO THE INFORMATION REGARDING OTHER PLATFORM THE DISCREPANT TEST WAS PERFORMED ON AND HAS NO DATA. REPEAT TESTING WAS PERFORMED ON DIFFERENT SAMPLES. SAMPLE SENT TO OTHER LAB WAS COLLECTED ON (B)(6) 2024 AND SENT TO OTHER LAB ON THE SAME DAY, REPORT CONFIRMS DATE OF RECEIPT ON (B)(6) 2024. TEST RELEASED ON (B)(6) 2024, WITH NO INFORMATION ON THE CONDITIONS UNDER WHICH THIS SAMPLE WAS SENT AND STORED AT OTHER LAB. THE XPRESS FLU/RSV RESULT WAS REPORTED TO THE PHYSICIAN. THE DOCTOR CONSULTED THE PATIENT'S REPORT AND CHECKED ALL THE UNDETECTED RESULTS, SO THE PATIENT WAS NOT SENT TO AN ISOLATION BED. PATIENT IN ICU BED TREATED FOR ACUTE VIRAL BRONCHIOLITIS, FURTHER TESTS WERE REQUESTED TO INVESTIGATE THE ETIOLOGIC AGENT. PATIENT AGE WAS 2 MONTHS AND PRESENTED WITH CLINICAL CONDITION OF ACUTE VIRAL BRONCHIOLITIS. PATIENT STARTED SHOWING SYMPTOMS ON MAY 21, CAME TO THE EMERGENCY ROOM WITH A COUGH AND NASAL CONGESTION. NEBULIZATION WITH CLENIL WAS STARTED. PATIENT RETURNED ON (B)(6) 2024 CUSTOMER STATING "LAST WEEK HE WAS IN THE SERVICE, HE HAD SECRETIONS IN HIS AIRWAYS, HE WAS TREATED WITH CLENIL FOR 5 DAYS. YESTERDAY SHE STARTED HAVING SECRETIONS IN HER EYES AND AIRWAYS, AND HAD A PRODUCTIVE COUGH, SOMETIMES CHOKING ON HER COUGH. DIFFICULTY SUCKLING. NO FEVER. SHE CONSULTED HER PEDIATRICIAN ONLINE, WHO ASKED HER TO COME TO THE ER. HAS A 4-YEAR-OLD BROTHER WHO ATTENDS NURSERY SCHOOL. MOTHER HAS ASTHMA." DISCHARGED WITH PRESCRIPTION AFTER X-RAY AND IMPROVEMENT IN SYMPTOMS. PATIENT RETURNED TO THE ER ON (B)(6) 2024 CUSTOMER STATING "MOTHER HAS BEEN REPORTING FLU-LIKE SYMPTOMS FOR A WEEK, WORSENING THIS MORNING. TODAY SHE STARTED WITH A FEVER. NORMAL URINE AND STOOLS. NO VOMITING. DIFFICULTY BREASTFEEDING. CONTACT WITH 4-YEAR-OLD BROTHER WHO ATTENDS NURSERY SCHOOL. HE TOOK CLENIL A AND SALBUTAMOL, WITH NO IMPROVEMENT." ON THE SAME DAY, (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE ICU AND IS STILL HOSPITALIZED TODAY. CUSTOMER STATED PATIENT WAS IN A SHARED ROOM BUT NOT WITH ANOTHER RSV-POSITIVE CHILD. CLENIL IS THE ONLY PRESCRIPTION THE PATIENT USED. THE CHILD WAS ADMITTED TO THE ICU ON (B)(6) 2024. REVIEW OF THE INITIAL XPRESS FLU/RSV TEST RESULTS SHOWS NO TARGETS DETECTED. THE INTERNAL CONTROL WAS DETECTED HOWEVER THE SINGLE IS DELAYED AND SOMEWHAT WEAK, WITH AN ODD SHAPE. A FEW OPTIONS FOR LIKELY ROOT CAUSE OR AVAILABLE, SUCH AS INADEQUATE SAMPLE COLLECTION OR PROCESSING, DIFFERENCES IN SAMPLE COLLECTION (I.E. SAMPLE BIAS) BETWEEN THE TWO SAMPLES AND/OR PRESENCE OF AN INHIBITOR IN LOW CONCENTRATION. PATIENT APPEARS TO HAVE BEEN TREATED WITH CLENIL IN THE DAYS PRIOR TO TESTING. THIS DRUG HAS NOT BEEN TESTED FOR INTERFERENCE ON THE PRODUCT IFU. FOR A SAMPLE WITH RSV TARGET AT OR BELOW THE LIMIT OF DETECTION FOR THE TEST, THESE FACTORS COULD CONTRIBUTE TO A FALSE-NEGATIVE RESULT. IT IS ALSO POSSIBLE THAT THE PATIENT'S VIRAL LOAD INCREASED BETWEEN THE ORIGINAL TEST ON (B)(6) 2024 AND THE SECTION SAMPLE ACQUISITION ON (B)(6) 2024. AS SUCH, THIS SECOND SAME MAY HAVE CONTAINED A DETECTABLE QUANTITY OF GENETIC MATERIAL, WHEREAS THE FIRST SAMPLE DID NOT. PATIENT APPEARS TO HAVE RECEIVED APPROPRIATE TREATMENT FOR ACUTE BRONCHITIS REGARDLESS OF DEFINITIVE RSV STATUS. HOWEVER, GIVEN THE ON-LABEL USE OF THIS TEST, THE CONTINUED ILLNESS OF THE ORIGINAL PATIENT, AND THE RISK OF SECONDARY EXPOSURE TO OTHER PATIENTS. AS OF (B)(6) 2024, THE CHILD IS STILL SICK. 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

    AFTER FURTHER INVESTIGATION, THIS CASE WAS DEEMED NOT REPORTABLE. SECTION H6 INVESTIGATION FINDINGS AND INVESTIGATIONS CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT THE OUTCOME OF THE INVESTIGATION. CEPHEID RECEIVED NEW INFORMATION FROM THE CUSTOMER ON 12-AUG-2024 THAT THE CHILD WAS DISCHARGED ON (B)(6) 2024 AFTER IMPROVING. THE CUSTOMER DID NOT INDICATE THAT A RETEST WAS PERFORMED. THE LIKELY ROOT CAUSE IN THIS CASE IS INCONCLUSIVE. CEPHEID INVESTIGATION SHOWED NO INDICATION OF MALFUNCTION IN THE TEST FOR EITHER CARTRIDGE OR SYSTEM. ADF 6 WAS DESIGNED TO CALL THIS A NEGATIVE RESULT AS OPPOSED TO THE OLD ADF WHICH WOULD HAVE RESULTED IN AN ERROR.

    Description of Event or Problem · 0

    BRAZIL CUSTOMER CONTACTED CEPHEID ON (B)(6) 2024 TO DISCUSS A DISCREPANT RESULT OF A XPERT XPRESS FLU-RSV TEST. PATIENT WAS BORN ON (B)(6) 2024. THE SAMPLE WAS COLLECTED AND TESTED ON (B)(6) 2024 AND RAN XPERT XPRESS FLU-RSV WHICH RESULTED IN NEGATIVE FOR FLU A, FLU B AND RSV. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2024 AND SENT TO ANOTHER LAB WITH POSITIVE RESULT FOR RSV. REPORT NOT PROVIDED TO CEPHEID.

    Description of Event or Problem · 0

    US CUSTOMER CONTACTED CEPHEID ON 18-JUN-2024 TO DISCUSS A DISCREPANT RESULT OF A XPERT XPRESS FLU-RSV TEST. PATIENT WAS BORN ON (B)(6) 2024. THE SAMPLE WAS COLLECTED AND TESTED ON (B)(6) 2024 AND RAN XPERT XPRESS FLU-RSV WHICH RESULTED IN NEGATIVE FOR FLU A, FLU B AND RSV. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2024 AND SENT TO ANOTHER LAB WITH POSITIVE RESULT FOR RSV. REPORT NOT PROVIDED TO CEPHEID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978609 XPERT XPRESS FLU/RSV (CE) XPERT XPRESS FLU/RSV OCC CEPHEID 1001329493

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Unknown Other