BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST FOSFOMYCIN FM 1024 WW B30

    MDR report key: 9967419 · Received April 16, 2020

    Report

    Report Number
    9615754-2020-00068
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JWY
    PMA / PMN Number
    K981136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF A FALSE SUSCEPTIBLE RESULT FOR KLEBSIELLA PNEUMONIAE WHEN TESTING A NEQAS SURVEY SAMPLE WITH THE ETEST® FOSFOMYCIN FM 1024 WW B30 (REF 529100, LOT 1006972040). ---COMPLAINT TREND ANALYSIS--- NO OTHER COMPLAINTS HAVE BEEN REGISTERED FOR THE LOT NUMBER 1006972040 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED FOR FALSE SUSCEPTIBLE RESULTS ON ETEST FOSFOMYCIN (FM1024) WITH A KLEBSIELLA PNEUMONIAE EXTERNAL QUALITY CONTROL (EQC) STRAIN FROM UK NEQAS. ---ETEST BATCH QUALITY CONTROL--- QUALITY CONTROL TESTING WAS PERFORMED USING THE CUSTOMER'S LOT (1006972040) AND AN INTERNAL REFERENCE LOT (1007623650). ATCC® STRAIN TESTED : [EXPECTED RANGE G/ML]. ESCHERICHIA COLI ATCC® 25922: [0.5 - 2]. ENTEROCOCCUS FAECALIS ATCC® 29212: [16 - 64]. STAPHYLOCOCCUS AUREUS ATCC® 29213: [0.25 - 2]. PSEUDOMONAS AERUGINOSA ATCC® 27853: [2 - 8]. THE EXPECTED RANGES WERE OBTAINED FOR ALL ATCC® STRAINS ON BOTH LOTS TESTED. ---REPRODUCIBILITY TESTING AND REFERENCE METHOD--- THE CUSTOMER'S STRAIN WAS SUBMITTED FOR INVESTIGATIONAL TESTING. THE CUSTOMER'S STRAIN AND AN INTERNAL REFERENCE STRAIN WERE TESTED IN AN EFFORT TO REPRODUCE THE CUSTOMER'S RESULTS. THE IDENTIFICATION OF BOTH STRAINS WAS CONFIRMED TO BE KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE WITH THE VITEK® 2 GN ID TEST KIT (LOT 2411125403). THE AGAR DILUTION (AD) METHOD WAS USED TO DETERMINE THE EXPECTED FOSFOMYCIN MIC AS THE AD METHOD IS THE REFERENCE METHOD FOR THE DEVELOPMENT OF THE ETEST PRODUCT. MIC = 32 MG/L (SUSCEPTIBLE). BOTH STRAINS WERE THEN TESTED WITH RETAIN SAMPLES OF THE ETEST FOSFOMYCIN FM 1024 FROM THE CUSTOMER'S LOT (1006972040) AND THE INTERNAL REFERENCE LOT (1007623650). CUSTOMER STRAIN RESULTS: 16 G/ML (SUSCEPTIBLE) ON CUSTOMER'S LOT. 32 G/ML (SUSCEPTIBLE) ON THE REFERENCE LOT. INTERNAL REFERENCE STRAIN RESULTS: 32 G/ML (SUSCEPTIBLE) ON THE CUSTOMER'S LOT. 32 G/ML (SUSCEPTIBLE) ON THE REFERENCE LOT. ---CONCLUSION--- THE ETEST FM1024 SUSCEPTIBLE RESULTS OBTAINED BY THE CUSTOMER WERE REPRODUCED IN-HOUSE ON THE CUSTOMER'S LOT AND ON THE INTERNAL REFERENCE LOT. THE ETEST RESULTS ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE MIC AND NO CATEGORY ERROR. THE INVESTIGATION HAS CONCLUDED THAT THIS PRODUCT IS PERFORMING AS EXPECTED. IT SHOULD BE NOTED THAT 37.5% OF PARTICIPANTS IN THE NEQAS SURVEY OBTAINED SUSCEPTIBLE RESULTS WHILE THE EXPECTED RESULT WAS MIC = 128 G/ML (RESISTANT).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMRIEUX OF A FALSE SUSCEPTIBLE RESULT FOR KLEBSIELLA PNEUMONIAE WHEN TESTING A NEQAS SURVEY SAMPLE WITH THE ETEST FOSFOMYCIN FM 1024 WW B30 (REF 529100, LOT 1006972040). AS THIS WAS A NEQAS SURVEY SAMPLE, THERE IS NO PATIENT INVOLVED. REPEAT ANALYSIS WITH ETEST ALSO OBTAINED A SUSCEPTIBLE RESULT. INITIAL: FOSFOMYCIN MIC = 24 MG/L (SUSCEPTIBLE) REPEAT: FOSFOMYCIN MIC = 12 MG/L (SUSCEPTIBLE) EXPECTED: FOSFOMYCIN = RESISTANT REF 529100 IS NOT MARKETED OR SOLD IN THE UNITED STATES. THE US VERSION OF THE PRODUCT IS REF 529140 (K981136). A BIOMRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431541 ETEST FOSFOMYCIN FM 1024 WW B30 FOSFOMYCIN FM 1024 WW B30 - 529100 JWY BIOMERIEUX SA 1006972040

    Patients

    Seq Age Sex Outcome Treatment
    1