BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEFOTAXIME CTL 32 US S30

    MDR report key: 5083567 · Received September 17, 2015

    Report

    Report Number
    3002769706-2015-00087
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Report Date
    July 21, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JWY
    PMA / PMN Number
    K981137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE UNITED STATES REPORTED PSEUDOMONAS AERUGINOSA ATCC® 27853 TM OUT-OF-RANGE-HIGH (MIC >=32) IN ASSOCIATION WITH ETEST® CEFOTAXIME CTL 32. INTERNAL INVESTIGATION WAS CONDUCTED. ETEST® CEFOTAXIME CTL 32 IS ONLY RECOMMENDED FOR STREPTOCOCCUS AND FASTIDIOUS STRAINS. ETEST® CEFOTAXIME CTL 32 IS NOT ADAPTED FOR PSEUDOMONAS AERUGINOSA. THIS IS WHY PSEUDOMONAS AERUGINOSA ATCC® 27853 TM IS NOT RECOMMENDED FOR QUALITY CONTROL TESTING AGAINST THIS PRODUCT. INSTRUCTIONS FOR USE SUPPLEMENTARY INSERT US 15221 STATES TO "PLEASE CONSULT THE FOOTNOTES IN THE LATEST CLSI TABLES FOR FURTHER COMMENTS AND CLARIFICATION. INTERPRETIVE CRITERIA MAY BE DIFFERENT." IN CLSI, THERE ARE NO BREAK POINTS FOR PSEUDOMONAS AERUGINOSA. THE ETEST® CEFOTAXIME CTL 32 PRODUCT IS PERFORMING IN ACCORDANCE TO PERFORMANCE CLAIMS.

    Description of Event or Problem · 1

    A CUSTOMER CALLED WITH OUT OF RANGE RESULTS FOR QC TESTING USING ETEST CEFOTAXIME CTL 32 US S30, (B)(4), LOT 1004047910. QUALITY CONTROL TESTING FOR PSEUDOMONAS AERUGINOSA 27853 WERE OUT OF RANGE (HIGH) AND E. COLI 25922 WAS ACCEPTABLE. ADDITIONAL SET-UP AND TESTING PERFORMED WITH THE SAME RESULTS. PRODUCT FROM A DIFFERENT LOT ARE BEING SENT TO THE CUSTOMER FOR USE. AN INTERNAL INVESTIGATION HAS BEEN LAUNCHED. THERE WAS NO REPORTED DEATH OR SERIOUS INJURY ASSOCIATED WITH THE REFERENCED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614739 CEFOTAXIME CTL 32 US S30 CEFOTAXIME CTL 32 US S30 JWY BIOMERIEUX SA 1004047910

    Patients

    Seq Age Sex Outcome Treatment
    1