BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MANNITOL SALT AGAR

    MDR report key: 13023141 · Received December 16, 2021

    Report

    Report Number
    1119779-2021-01986
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 22, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THIS EVENT WAS A QC FAILURE AND IS NOT REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. IN THIS PARTICULAR EVENT, THE DIAGNOSTIC TEST IS PERFORMED WITH THE UNDERSTANDING AND RECOMMENDATION TO PERFORM CONCURRENT CONTROLS TO ASSURE ACCURACY. THEREFORE, ERRONEOUS RESULTS WOULD BE SUSPECTED AND LEAD TO RETESTING. THIS WILL NOT LIKELY LEAD TO A SERIOUS ADVERSE EVENT. THEREFORE, THIS COMPLAINT WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MANNITOL SALT AGAR PLATE HAD ATYPICAL GROWTH ISSUES, WHERE THE E.COLI COLONY HAD A BREAKTHROUGH AND GPT FAILED TO GROW THROUGH IT. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THIS EVENT OCCURRED 3 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTED A DISTINCT DIFFERENCE IN THE PERFORMANCE OF THIS LOT OF DCM (211407, LOT 0315698) WHEN COMPARED WITH PREVIOUS LOTS OF MATERIAL USED. WE ARE OBSERVING BREAKTHROUGH (NO INHIBITION) OF E.COLI ATCC8739 ON FINAL PREPARED MEDIA PLATES MANUFACTURING USING DCM 211407 LOT 0315698."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MANNITOL SALT AGAR PLATE HAD ATYPICAL GROWTH ISSUES, WHERE THE E.COLI COLONY HAD A BREAKTHROUGH AND GPT FAILED TO GROW THROUGH IT. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THIS EVENT OCCURRED 3 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTED A DISTINCT DIFFERENCE IN THE PERFORMANCE OF THIS LOT OF DCM (211407, LOT 0315698) WHEN COMPARED WITH PREVIOUS LOTS OF MATERIAL USED. WE ARE OBSERVING BREAKTHROUGH (NO INHIBITION) OF E.COLI ATCC8739 ON FINAL PREPARED MEDIA PLATES MANUFACTURING USING DCM 211407 LOT 0315698."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920270 BD BBL¿ MANNITOL SALT AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 0315698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown