BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID ID 32 STREP 25STRIPS - 32600

    MDR report key: 18111107 · Received November 10, 2023

    Report

    Report Number
    9615754-2023-00051
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Report Date
    April 11, 2024
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JTO
    UDI-DI
    03573026066536
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT THAT THE CUSTOMER OBSERVED "STRANGE POSITIVE REACTIONS" WHILE TESTING A PATIENT STREPTOCOCCUS DYSGALACTIAE SSP. EQUISIMILIS STRAIN WITH THE RAPID ID 32 STREP (REF 32600, LOT 1009964540). ---INVESTIGATION--- COMPLAINT TREND ANALYSIS: ON 04APR2024, A COMPLAINT TREND ANALYSIS WAS PERFORMED SINCE 2020 ON THE PRODUCT REFERENCE 32600. THE COMPLAINT TREND ANALYSIS DOES NOT SHOW ANY NEGATIVE TREND FOR THE PRODUCT RAPID ID 32 STREP, REFERENCE 32600. RETAINED SAMPLES ANALYSIS: BIOMÉRIEUX RETAINS SAMPLES OF EVERY LOT NUMBER RELEASED TO THE MARKET. THE RETAINED SAMPLES FROM THE IMPACTED LOT NUMBER 1009964540 WERE TESTED IN PARALLEL WITH AN INTERNAL LOT NUMBER USED AS A REFERENCE LOT (REFERENCE 32600, LOT 1009887700, EXPIRY DATE 15 FEB 2024). THE TESTS WERE PERFORMED BY USING THE QUALITY CONTROL (QC) STRAINS STREPTOCOCCUS EQUI SSP EQUI ATCC 33398, STREPTOCOCCUS AGALACTIAE ATCC 12401 AND STREPTOCOCCUS VESTIBULARIS ATCC 49124 MENTIONED IN THE PACKAGE INSERT 07924 K. COMPLIANT RESULTS WERE OBTAINED FOR THE THREE STRAINS TESTED ON THE TWO RAPID ID 32 STREP LOT NUMBERS TESTED. STRAIN RETURN ANALYSIS: THE CUSTOMER PROVIDED THE STRAIN FOR INVESTIGATIONAL TESTING. THE STRAIN WAS TESTED ON THE IMPACTED LOT NUMBER 1009964540 AND ON A REFERENCE LOT OF THE PRODUCT REFERENCE 32600. THE IDENTIFICATION RESULTS OBTAINED WERE A VERY GOOD IDENTIFICATION TO STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS ON BOTH LOTS. THE ANALYSIS OF THE BIOCHEMICAL PROFILE OBTAINED DURING THE INVESTIGATION (11132041110) COMPARED TO THE PROFILE YOU OBTAINED ALLOWED TO HIGHLIGHT A DIFFERENCE OF RESULTS PARTICULARLY FOR THE SEVEN FOLLOWING TESTS : MAN, SOR, RAF, MEL, MLZ, DARL AND BMAN. NEGATIVE RESULTS WERE OBTAINED DURING THE INVESTIGATION WHILE THE CUSTOMER OBTAINED POSITIVE RESULTS. THESE SEVEN TESTS ARE EXPECTED TO BE NEGATIVE (0%) AS INDICATED IN THE DATABASE OF THE PRODUCT REFERENCE 32600 FOR STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS STRAINS. CONCLUSION: NO PRODUCT ISSUE WAS OBSERVED ON THE LOT NUMBER 1009964540 DURING THE TESTS PERFORMED ON THE RETAINED SAMPLES WITH THE THREE QC STRAINS TESTED. THE RESULTS THAT THE CUSTOMER OBTAINED WERE NOT REPRODUCED DURING THE INVESTIGATION WITH THE IMPACTED STRAIN: A VERY GOOD IDENTIFICATION TO STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS WAS OBTAINED ON THE COMPLAINED LOT NUMBER 1009964540 AND ON THE REFERENCE LOT. THE COMPLAINT TREND ANALYSIS DOES NOT SHOW ANY NEGATIVE TREND FOR THE PRODUCT RAPID ID 32 STREP, REFERENCE 32600.

    Description of Event or Problem · 0

    INTENDED USE: RAPID ID 32 STREP IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF STREPTOCOCCI AND ENTEROCOCCI, AND THOSE MOST COMMON RELATED ORGANISMS, IN FOUR HOURS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIFICALLY ADAPTED DATABASE. AFTER MANUAL INOCULATION OF THE STRIP, READING CAN BE PERFORMED EITHER AUTOMATICALLY OR MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. ISSUE DESCRIPTION: A CUSTOMER IN JAPAN NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED "STRANGE POSITIVE REACTIONS" WHILE TESTING A PATIENT STREPTOCOCCUS DYSGALACTIAE SSP. EQUISIMILIS STRAIN WITH THE RAPID ID 32 STREP (REF 32600, LOT 1009964540). THE CUSTOMER REPORTED THAT THEY TESTED THE S. DYSGALACTIAE SSP. EQUISIMILIS STRAIN RANDOMLY NINE (9) TIMES, AND DURING THREE (3) OF THE TESTS THE ENTIRE TOP ROW OF THE TEST KIT TURNED RED. THE CUSTOMER PROVIDED RESULTS FROM SEVEN (7) TESTS INCLUDING 4 UNACCEPTABLE PROFILES AND 3 GOOD PROFILES. THERE IS NO EVIDENCE OF A MISIDENTIFICATION. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804952 RAPID ID 32 STREP 25STRIPS - 32600 RAPID ID 32 STREP 25STRIPS - 32600 JTO BIOMÉRIEUX SA 1009964540 03573026066536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown