BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST® CIPROFLOXACIN CI 32 WW S30

    MDR report key: 5491704 · Received March 10, 2016

    Report

    Report Number
    3002769706-2016-00051
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Report Date
    March 7, 2016
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JWY
    PMA / PMN Number
    K981138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH ETEST® CIPROFLOXACIN CI 32 INVOLVING FAILED QUALITY CONTROL (QC) RESULTS FOR PSEUDOMONAS AERUGINOSA ATCC 27853 SAMPLE. THE QC RESULTS OBTAINED BY THE CUSTOMER WERE OUT OF RANGE LOW. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: -QC TESTS WERE PERFORMED WITH ETEST® CIPROFLOXACIN CI 32 AND PSEUDOMONAS AERUGINOSA ATCC 27853. THE QC TESTS WERE PERFORMED 3 TIMES WITH THE CUSTOMERS LOT. RESULTS- QC RESULTS OBTAINED WITH PSEUDOMONAS AERUGINOSA ATCC 27853, WERE NOT CONFORM. THE CUSTOMER'S ISSUE WAS REPRODUCED. QC VALUES OBTAINED WITH THIS STRAIN WERE BELOW THE LIMIT VALUES OF THE RANGE: 0.25 UG/ML. HOWEVER, NO REFERENCE BATCH WAS TESTED IN PARALLEL. THEREFORE, A COMPLEMENTARY STUDY WAS PERFORMED ON ATCC 27853 AND PSEUDOMONAS CLINICAL STRAINS. -THE PSEUDOMONAS AERUGINOSA ATCC 27853 WAS TESTED WITH ALL THE LOTS OF ETEST® CIPROFLOXACIN CI 32 FOAM AND SPB (NOT ALREADY EXPIRED AND AVAILABLE ON THE MARKET) ON MHE AND MH BD AGAR. RESULTS- 130 STRIPS HAVE BEEN TESTED ON MHE AGAR: FIVE (5) NON-CONFORMITIES WERE OBSERVED (MIC: 0.125 UG/ML) - 3.8% OF NON-CONFORMED RESULTS; 130 HAVE BEEN TESTED ON MHBD AGAR - RESULTS WERE CONFORMED FOR ALL LOTS. ON 260 STRIPS TESTED, WITH ANY AGAR USED, ONLY FIVE (5) NON-CONFORMITIES (MIC: 0.125 UG/ML) HAVE BEEN DETECTED WITH PSEUDOMONAS AERUGINOSA ATCC 27853, MEANING 1.9% NON-CONFORMITY. IN CONCLUSION, THE RATE OF THE NON-CONFORMITY ON THE LOTS IN THE MARKET IS 1.9% (3.8% WHEN ETEST® CIPROFLOXACIN CI 32 IS USED ON MHE AGAR, 0% WHEN USING MHBD AGAR); THEREFORE, WITHIN THE ACCEPTANCE CRITERIA OF THE FDA AND ISO STANDARD (<=5%). -AN INVESTIGATION WAS PERFORMED WITH A COMPLEMENTARY KIT (44 STRAINS) OF PSEUDOMONAS CLINICAL STRAINS WITH ETEST® CIPROFLOXACIN CI 32 ON MHE AND MH BD AGAR. THE STRAINS TESTED WERE REPRESENTATIVE OF THE CONCENTRATION RANGE OF ETEST® CIPROFLOXACIN CI 32 AND OF THE CRITICAL CONCENTRATIONS OF CLSI AND EUCAST STANDARDS. TWENTY- ONE (21) OF THE 44 STRAINS HAD A MIC VALUE BETWEEN (0.5-4MG/L) CORRESPONDING TO THE CRITICAL CONCENTRATIONS OF THE EUCAST AND CLSI STANDARDS. THIS SPECIFIC SELECTION OF THE STRAINS AND THE PRECISION OF THE ANTIBIOTIC SUSCEPTIBILITY TESTING METHOD THAT IS CURRENTLY ACCEPTED (+/- 1 DILUTION), COULD LEAD TO AN INCREASE OF THE MINOR ERRORS (THRESHOLD EFFECT). -THEN, IN PARALLEL, THE QC STRAIN P. AERUGINOSA ATCC 27853 WAS ALSO TESTED. REFERENCE METHODS USED: -AGAR DILUTION (AD) METHOD - REFERENCE METHOD USED AT THE MOMENT OF THE REGISTRATION OF THE ETEST® CIPROFLOXACIN CI 32 PRODUCT. -BROTH MICRO-DILUTION (BMD) METHOD - REFERENCE METHOD RECOGNIZED BY THE CLSI AND EUCAST USED AS A COMPLEMENTARY METHOD TO COMPLETE THE CHARACTERIZATION LEVEL OF THE STRAINS TO EVALUATE THE CLINICAL IMPACT OF POTENTIAL DISCREPANCIES WITH THE AGAR DILUTION (AD) METHOD. THE RESULTS OF THE DIFFERENT STUDIES STATE THE FOLLOWING: THE RESULTS OBTAINED DURING THE DIFFERENT STUDIES ON PSEUDOMONAS AERUGINOSA STRAINS STATE THAT ETEST® CIPROFLOXACIN CI 32 COULD LEAD TO A POTENTIAL SPECIFICATIONS OUTPUT FOR THE QC P. AERUGINOSA ATCC 27853 STRAIN (MIC: 0.125 UG/ML LOWEST VALUE FOR AN EXPECTED RANGE BETWEEN MIC: 0.25-1 UG/ML) FOR LESS THAN 5% OF THE STRIPS TESTED (ACCEPTED RATE FOR THE FDA AND ISO) BUT WITHOUT ANY IMPACT ON PRODUCT PERFORMANCE; THEREFORE, WITH NO PATIENT RISK BASED ON THIS STUDY. IN CONCLUSION OF THE REVIEW OF THIS ISSUE, NO ADDITIONAL ACTIONS DEEMED NECESSARY IN THE FIELD.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED REPEATED LOW RANGE OF QC RESULTS; CIPROFLOXACIN WITH PSEUDOMONA AERUGINOSA ATCC 27853 WHILE USING; ETEST&#59395;CIPROFLOXACIN CI 32 WW S30. THERE IS NO EVIDENCE/INDICATION OF THE FOLLOWING: INJURY OR DEATH TO A PATIENT, EVIDENCE THAT A PATIENT UNDERWENT ANY UNNECESSARY MEDICAL PROCEDURE DUE TO THE REPORTED EVENT, PHYSICIAN ALLEGING THE REPORTED EVENT CAUSED HIM/HER TO PROVIDE INCORRECT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147545 ETEST® CIPROFLOXACIN CI 32 WW S30 ETEST® CIPROFLOXACIN CI 32 WW S30 JWY BIOMERIEUX, SA 1004075180

    Patients

    Seq Age Sex Outcome Treatment
    1