BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST® DAPTOMYCIN DPC 256 WW S30

    MDR report key: 7541768 · Received May 24, 2018

    Report

    Report Number
    3002769706-2018-00068
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Report Date
    June 26, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JWY
    PMA / PMN Number
    K042392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    256 WW S30 (REF 412324) LOT 1005932460. AN INVESTIGATION WAS PERFORMED. TESTING WAS PERFORMED ON RETAINED SAMPLES OF ETEST DAPTOMYCIN DPC 256 S30 (LOT 005932460), AND ETEST DAPTOMYCIN DPC 256 WW F100 (LOT 1004343910) IN PARALLEL WITH ANOTHER BATCH AS A REFERENCE (LOT 1006198630). THREE QC STRAINS WERE TESTED: STAPHYLOCOCCUS AUREUS ATCC 29213 AND ENTEROCOCCUS FAECALIS ATCC 29212 WERE TESTED ON TWO MUELLER HINTON MEDIA: ONE LOT OF MH-E BIOMÉRIEUX AND ONE LOT OF MH-BD PRE-POURED. STREPTOCOCCUS PNEUMONIAE ATCC 49619 WAS TESTED ON ONE LOT OF MH BLOOD, PRODUCED IN-HOUSE WITH BD POWDER. THE CUSTOMERS ISSUE WAS REPRODUCED WITH: - STAPHYLOCOCCUS AUREUS ATCC 29213: LOT 1004343910 AND MH-E MEDIA HAD TWO STRIPS ON THREE AT 0.125 ¿G/ML - ENTEROCOCCUS FAECALIS ATCC 29212: ALL THREE LOTS AND MH-E MEDIA HAD ONE OR TWO STRIPS ON THREE AT 0.5 ¿G/ML. ALL DATA WAS COMPLIANT WITH: - STREPTOCOCCUS PNEUMONIAE ATCC 49619 ON MH BLOOD (PRODUCED IN-HOUSE WITH BD POWDER. - STAPHYLOCOCCUS AUREUS ATCC 29213 AND ENTEROCOCCUS FAECALIS ATCC 29212) ON MH-BD PRE-POURED. AS EXPLAINED IN THE ETEST CUSTOMER INFORMATION SHEET CIS 014, DAPTOMYCIN REQUIRES PHYSIOLOGIC LEVELS OF FREE CALCIUM (CA2+) FOR EXPRESSION OF ADEQUATE ACTIVITY. THE BIOAVAILABLE FREE CA2+ LEVELS IN BRANDS AND BATCHES OF MHA POWDER AND COMMERCIAL MHA PLATES CAN VARY SIGNIFICANTLY AND AFFECT ETEST DPC RESULTS. CONCLUSION: NO LOSS OF PERFORMANCE WAS FOUND DURING THE INVESTIGATION. HOWEVER, IT WAS CONFIRMED THAT THE SOURCE OF THE MEDIA COULD IMPACT THE READING OF THE MIC VALUE. THIS DOESN'T MEAN THAT PARTICULAR MEDIA ARE NOT COMPATIBLE WITH ETEST BUT THAT THE COMPOSITION IS DIFFERENT. MIC VALUES MAY VARY BATCH TO BATCH AND IT IS IMPORTANT TO TEST QC STRAINS TO VALIDATE THE USE OF THE LOT OF MEDIA.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED OUT OF RANGE LOW RESULTS FOR INTERNAL QUALITY CONTROLS (QC) IN ASSOCIATION WITH ETEST® DAPTOMYCIN DPC 256 WW S30 (REF 412324) LOT 1005932460. THE CUSTOMER STATED THAT WHEN THEIR QC IS WITHIN RANGE IT IS ALWAYS AT THE VERY LOWEST END OF THE QC RANGE FOR BOTH THE STAPHYLOCOCCUS AUREUS ATCC® 29213 AND ENTEROCOCCUS FAECALIS ATCC® 29212. THE CUSTOMER REPORTED THAT WHEN THE QC IS OUT OF RANGE, IT IS ALWAYS LOWER THAN EXPECTED. THE CUSTOMER REPORTED THAT RESULTS WERE DELAYED AT LEAST 72 HOURS FOR TWO (2) PATIENTS (WITH VRE IN THE BLOOD) DUE TO THE DAPTOMYCIN QC FAILING AT LEAST TWICE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. REFERENCE 412324, ETEST® DAPTOMYCIN DPC 256 WW S30, IS NOT APPROVED IN THE UNITED STATES, HOWEVER, THE EQUIVALENT PRODUCT, REFERENCE 412323 ETEST® DAPTOMYCIN DPC 256 WW S30 IS APPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385227 ETEST® DAPTOMYCIN DPC 256 WW S30 ETEST® DAPTOMYCIN DPC 256 WW S30 JWY BIOMERIEUX SA 1005932460

    Patients

    Seq Age Sex Outcome Treatment
    1