BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 14087834 · Received April 12, 2022

    Report

    Report Number
    3010141591-2022-00007
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 16, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. 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

    H.6 INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT THEY COULD NOT MARK A SECOND ISOLATE ON AN AST PLATE. THIS WAS LOGGED AGAINST SYNAPSYS MATERIAL #444150, SERIAL #SL00578. THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. THE CUSTOMER WANTED A WORKFLOW THAT IS NOT SUPPORTED IN SYNAPSYS. A WORKAROUND WAS PROVIDED THAT ADDRESS THE CUSTOMER ISSUE. THE ISSUE IS RESOLVED. BD WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYNAPSYS¿ COULD NOT MARK A SECOND ISOLATE ON THE PLATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A AST PLATE IS CREATED AGAINST ISOLATE 1 FOR EXAMPLE AND THE USER NOTICES A COLONY GROWING IN A ZONE AND NEED TO FOLLOW THAT AS A SECOND ISOLATE. SYNAPSYS ALLOWS YOU TO MARK A ISOLATE ON THE PLATE HOWEVER IT IS ALWAYS ISOLATE 1 AND NOT A SECOND ISOLATE WHICH IS WHAT THE USER WANTS TO FOLLOW."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYNAPSYS¿ COULD NOT MARK A SECOND ISOLATE ON THE PLATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A AST PLATE IS CREATED AGAINST ISOLATE 1 FOR EXAMPLE AND THE USER NOTICES A COLONY GROWING IN A ZONE AND NEED TO FOLLOW THAT AS A SECOND ISOLATE. SYNAPSYS ALLOWS YOU TO MARK A ISOLATE ON THE PLATE HOWEVER IT IS ALWAYS ISOLATE 1 AND NOT A SECOND ISOLATE WHICH IS WHAT THE USER WANTS TO FOLLOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072618 BD SYNAPSYS¿ NA JQP BD KIESTRA LAB AUTOMATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown