BEUDAMED
    FDA Adverse Event Death Summary report: N

    STREP A RAPID TEST STRIP (THROAT SWAB)

    MDR report key: 18976343 · Received March 25, 2024

    Report

    Report Number
    3005641941-2024-00002
    Event Type
    Death
    Date Received
    March 25, 2024
    Date of Event
    September 12, 2023
    Report Date
    March 26, 2024
    Manufacturer
    ABON BIOPHARM (HANGZHOU) CO., LTD.
    Product Code
    GTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. BASED ON CONSULTATION WITH THE SENIOR DIRECTOR OF MEDICAL, SCIENTIFIC AND CLINICAL AFFAIRS, THERE WAS NO CLEAR ASSOCIATION BETWEEN THE FALSE NEGATIVE STREP A RESULT AND THE PATIENT PASSING AWAY. DUE TO LIMITED INFORMATION TO MAKE A DEFINITIVE CONCLUSION. ALTHOUGH THERE IS NO DIRECT INFORMATION THAT INDICATES THAT THE FALSE NEGATIVE TEST RESULT CAUSED OR CONTRIBUTED TO THE PATIENT DEATH, THIS MDR IS BEING SUBMITTED CONSERVATIVELY BECAUSE A CONTRIBUTION COULD NOT BE RULED OUT. 2. DEATH OCCURRED; HOWEVER, THE CAUSE IS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENTS DIED AFTER TESTING FALSE (NEGATIVE - EDITED) BUT THERE IS NO SUSPECTED RELATIONSHIP BETWEEN THE DEATH AND THE USE OF THE PRODUCT. 3. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, BIOSYNEX S.A. STREP A RAPID TEST STRIP , MARKETED IN FRANCE, WHICH IS SAME/SIMILAR TO STREP A RAPID TEST STRIP MARKETED IN THE US UNDER LISTING NUMBER E647599, 510(K) K010582. BIOBYEX STREP A (COMPLAINED PRODUCT) AND STREP A RAPID TEST STRIP FOR THROAT SWAB SPECIMEN UNDER LISTING NUMBER E647599, 510(K) K010582 USE DIFFERENT PRODUCT NAMES, BUT SHARE THE SAME INTERNAL CATALOGUE IST-501D BECAUSE SAME FORMULATION. SO THEY ARE CONSIDERED AS SIMILAR PRODUCTS. 4. THE DATE INDICATED IN B3 DATE OF DEATH CONFIRMED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. 12SEP2023 IS THE DATE OF THE OFFICIAL WRITTEN STATEMENT AND DATE OF EVENT IS NOT KNOWN, SO USE THE 1ST DAY OF THE REPORTED MONTH-01SEP2023. 5. INVESTIGATION SUMMARY: THE BATCH RECORD WAS REVIEWED AND NO DEVIATION AS OBSERVED. THE RETAIN PRODUCT WAS PERFORMED AND NO FALSE NEGATIVE RESULT WAS OBSERVED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED BY THE DISTRIBUTOR OF A FALSE NEGATIVE RESULT REPORTED BY A MEDICAL PROFESSIONAL USING THE BIOSYNEX STREP A RAPID TEST STRIP (THROAT SWAB) CATALOG NUMBER IST-501, LOT 0000639258. THE REPORTER STATED THAT A DOCTOR PERFORMED A STREP A TEST ON A PATIENT AND THE TEST RESULT WAS NEGATIVE. THE PATIENT WAS REPORTED TO HAVE DIED AN UNKNOWN PERIOD OF TIME AFTER THE RESULT WAS OBTAINED. THE REPORTER RELAYED THAT THE PATIENT DEATH WAS CAUSED BY A STREPTOCOCCUS PYROGENES INFECTION. THE REPORTER WILL NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558702 STREP A RAPID TEST STRIP (THROAT SWAB) STREP A RAPID TEST STRIP (THROAT SWAB) GTY ABON BIOPHARM (HANGZHOU) CO., LTD. 0000639258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death