BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 15033038 · Received July 15, 2022

    Report

    Report Number
    1119779-2022-01000
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 17, 2022
    Report Date
    December 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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: THIS WAS LOGGED AGAINST SYNAPSYS MATERIAL #444150, SERIAL # (B)(6). THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. SYNAPSYS WORKS AS DESIGNED. THIS IS A REQUEST FOR CHANGE. THE CUSTOMER FAILED TO PROVIDE EXAMPLES TO ILLUSTRATE IMAGE QUALITY DIFFERENCES IN SYNAPSYS LOW ENOUGH TO CAUSE MISINTERPRETATIONS WHEN REQUESTED. THE IMAGES QUALITY IS HIGH ENOUGH TO SERVE ITS PURPOSES. DB MANAGER IMAGES ARE SLIGHTLY SHARPER THAN SYNAPSYS IMAGES. THIS IS A REQUEST FOR ENHANCEMENT. BD WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. DHR REVIEW IS NOT REQUIRED FOR STAND ALONE SOFTWARE. SOFTWARE OPERATION (OR FUNCTIONALITY) IS CONFIRMED AT TIME OF INSTALLATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE CUSTOMER EXPERIENCED APPLICATION ISSUES AFFECTING CULTURE READING WORKFLOW. ACCORDING TO THE CUSTOMER THERE ARE SIGNIFICANT DIFFERENCES WHEN COMPARING IMAGES BETWEEN DATABASE MANAGER AND SYNAPSYS. THE CUSTOMER FEELS THAT THE IMAGE QUALITY DIFFERENCES MAY LEAD TO MISINTERPRETATION. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN COMPARING IMAGES IN THE TWO APPLICATIONS THERE ARE SIGNIFICANT DIFFERENCES. OUTCOME INVESTIGATION ROBIN SMIT", "THEY BELIEVE THE IMAGE QUALITY DIFFERENCE IS LEADING TO THEM MAKING MISINTERPRETATIONS OF IMAGES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE CUSTOMER EXPERIENCED APPLICATION ISSUES AFFECTING CULTURE READING WORKFLOW. ACCORDING TO THE CUSTOMER THERE ARE SIGNIFICANT DIFFERENCES WHEN COMPARING IMAGES BETWEEN DATABASE MANAGER AND SYNAPSYS. THE CUSTOMER FEELS THAT THE IMAGE QUALITY DIFFERENCES MAY LEAD TO MISINTERPRETATION. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN COMPARING IMAGES IN THE TWO APPLICATIONS THERE ARE SIGNIFICANT DIFFERENCES. OUTCOME INVESTIGATION ROBIN SMIT", "THEY BELIEVE THE IMAGE QUALITY DIFFERENCE IS LEADING TO THEM MAKING MISINTERPRETATIONS OF IMAGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2892391 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown