BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDEC CARBA NP

    MDR report key: 7392395 · Received April 3, 2018

    Report

    Report Number
    3002769706-2018-00051
    Event Type
    Injury
    Date Received
    April 3, 2018
    Report Date
    June 13, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PTJ
    PMA / PMN Number
    K162385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH RAPIDEC CARBA NP (REFERENCE 415418). THE CUSTOMER SUBMITTED THE TWO PATIENT STRAINS FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE STRAINS WERE SUBCULTURED ON MHE MEDIA (AS MENTIONED IN THE PACKAGE INSERT CURRENT VERSION). USING A REFERENCE BATCH (KNOWN AS COMPLIANT), AND A RETENTION KIT OF BATCH1005914480, TESTS WERE PERFORMED WITH ONE STRIP WITH THE FOLLOWING STRAINS: ATCC BAA-1705 (POSITIVE REACTION) KLEBSIELLA PNEUMONIAE, MENTIONED IN THE PACKAGE INSERT CURRENT VERSION. STRAIN 1 - CITROBACTER FREUNDII. STRAIN 2 - KLEBSIELLA PNEUMONIAE. REFERENCE BATCH RESULTS: ATCC BAA-1705 KLEBSIELLA PNEUMONIAE STRAIN GAVE COMPLIANT RESULTS AT 30 MINUTES READING. STRAIN 1 - CITROBACTER FREUNDII, HAD NEGATIVE RESULTS AT 30 MINUTES, SO THE STRIPS WERE INCUBATED AGAIN FOR THE READING AT 2 HOURS WHICH WAS COMPLIANT. STRAIN 2 - KLEBSIELLA PNEUMONIAE GAVE COMPLIANT RESULTS AT 30 MINUTES AND 2 HOURS. BATCH 1005914480 RESULTS: ATCC BAA-1705 KLEBSIELLA PNEUMONIAE STRAIN GAVE COMPLIANT RESULTS AT 30 MINUTES READING. STRAIN 1 - CITROBACTER FREUNDII, HAD NEGATIVE RESULTS AT 30 MINUTES, SO THE STRIPS WERE INCUBATED AGAIN FOR THE READING AT 2 HOURS WHICH WAS COMPLIANT. STRAIN 2 - KLEBSIELLA PNEUMONIAE GAVE COMPLIANT RESULTS AT 30 MINUTES AND 2 HOURS. CONCLUSION OF THE INVESTIGATION: THERE IS NO DIFFERENCE OF INTERPRETATION OF RESULTS BETWEEN THE TWO BATCHES OF RAPIDEC CARBA NP STRIPS TESTED (1005914470 AND REFERENCE BATCH). THE RAPIDEC CARBA NP STRIPS BATCH 1005914480 HAS NO PERFORMANCE ISSUE, AND ALL THE RESULTS OBTAINED WERE COMPLIANT TO THE EXPECTED SPECIFICATIONS. AS MENTIONED IN THE PACKAGE INSERT REV 20584E-FR-2016/03, "THE USE OF MUELLER HINTON E (MHE) MEDIUM PROVIDES OPTIMAL PERFORMANCE DUE TO ITS GUARANTEED ZINC CONTENT". IN ADDITION THE PROCEDURE STATES, "IN CASE OF A NEGATIVE OR DOUBTFUL REACTION, REINCUBATE THE STRIP AND PERFORM A SECOND READING 1½ HOURS LATER. THE TOTAL TEST INCUBATION TIME MUST NOT EXCEED 2 HOURS".

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH RAPIDEC CARBA NP (REFERENCE 415418). THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS FOR RAPIDEC CARBA NP TWICE ON TWO (2) STRAINS FOR TWO (2) DIFFERENT PATIENTS WHILE THE CNRS CONFIRMED THAT IT WAS CARBAPENEMASES. THE PATIENT RETURNED FROM GABON, AND WAS TREATED WITH SURGICAL MANAGEMENT (DIGESTIVE) WITH ANTIBIOTICS (NON CARBAPENEMS). THERE WAS A DELAY >24 HOURS IN TREATMENT DUE TO THE CONFIRMATION BY THE CNR. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236133 RAPIDEC CARBA NP RAPIDEC CARBA NP PTJ BIOMERIEUX SA 1005914480

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention