BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL SENSI-DISC CEFEPIME - 30 G

    MDR report key: 11645008 · Received April 9, 2021

    Report

    Report Number
    3008352382-2021-00113
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    30382902316962
    PMA / PMN Number
    K961188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 3008352382-2021-00113 WAS SENT IN ERROR. IT WAS DETERMINED THE RESULTS WERE FOR A STUDY AND THEREFORE NOT REPORTABLE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ CEFEPIME - 30 G A FALSE SUSCEPTIBILITY RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: CUSTOMER REPORTS 231696 LOT: 0042052 HAS DISCREPANT RESULTS STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER IS PERFORMING A STUDY AND COMPARING BD SENSI DISCS TO VITEK 2 RESULTS. CUSTOMER REPORTS THAT THREE KLEBSIELLA PNEUMONIAE ESBL ISOLATES HAVE ZONES THAT INTERPRET AS RESISTANT BUT WHEN THE SAME ISOLATE IS RUN ON THE VITEK 2 THE RESULT IS SENSITIVE. FOLLOWED UP FOR ADDITIONAL DETAILS VIA PHONE BUT CUSTOMER HAS LEFT FOR THE DAY."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ CEFEPIME - 30 ¿G A FALSE SUSCEPTIBILITY RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS 231696 LOT: 0042052 HAS DISCREPANT RESULTS STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER IS PERFORMING A STUDY AND COMPARING BD SENSI DISCS TO VITEK 2 RESULTS. CUSTOMER REPORTS THAT THREE KLEBSIELLA PNEUMONIAE ESBL ISOLATES HAVE ZONES THAT INTERPRET AS RESISTANT BUT WHEN THE SAME ISOLATE IS RUN ON THE VITEK 2 THE RESULT IS SENSITIVE. FOLLOWED UP FOR ADDITIONAL DETAILS VIA PHONE BUT CUSTOMER HAS LEFT FOR THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543215 BD BBL SENSI-DISC CEFEPIME - 30 G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 231696 0042052 30382902316962

    Patients

    Seq Age Sex Outcome Treatment
    1