BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD STEM CELL CONTROL KIT 15 TESTS IVD

    MDR report key: 18321006 · Received December 13, 2023

    Report

    Report Number
    2916837-2023-00228
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    October 31, 2023
    Report Date
    June 20, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY BD BIOSCIENCES
    Product Code
    GGL
    UDI-DI
    00382903409914
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. REPORTING OFFICE CONTACT: (B)(6) - MDR. MANUFACTURING SITE CONTACT: (B)(6) - MDR. BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF HIGH CELL COUNTS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE OBTAINED REGARDING THE INDICATED FAILURE MODE WERE THE FOLLOWING: USER DATA WERE RETURNED INCLUDING RESULTS OF ANALYSIS SHOWING CUSTOMER CALCULATIONS. DOCUMENTATION FOR PART LOT 340991-BC1123 WAS REVIEWED AND MET SPECIFICATIONS PRIOR TO RELEASE. THE SUPPLIER INVESTIGATION DISCOVERED CUSTOMER MISCALCULATION THAT ACCOUNTED FOR RESULTS ABOVE EXPECTED VALUES. BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF HIGH CELL COUNTS WAS CONFIRMED. THE ISSUE WAS RESOLVED BY PROVIDING CUSTOMER WITH A REPLACEMENT LOT. THE REPLACEMENT LOT RESOLVED THE REPORTED ISSUE OF THE CUSTOMER COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY HAS BEEN CORRECTED. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF HIGH CELL COUNTS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE OBTAINED REGARDING THE INDICATED FAILURE MODE WERE THE FOLLOWING: ¿ USER DATA WERE RETURNED INCLUDING RESULTS OF ANALYSIS SHOWING CUSTOMER CALCULATIONS. ¿ DOCUMENTATION FOR PART LOT 340991-BC1123 WAS REVIEWED AND MET SPECIFICATIONS PRIOR TO RELEASE. ¿ THE SUPPLIER INVESTIGATION DISCOVERED CUSTOMER DECISIONS THAT ACCOUNTED FOR RESULTS ABOVE EXPECTED VALUES. THE ELEVATED NUMBER OF CD34+ CELLS CAN BE ATTRIBUTED BY THE GATING OF CD45+ LYMPHOCYTES. IT¿S RECOMMENDED TO USE APPROPRIATE GATING IN WHICH CD45 BRIGHT NONSPECIFIC EVENTS ARE REMOVED. ¿ THE REPLACEMENT LOT RESOLVED THE REPORTED ISSUE OF THE CUSTOMER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING BD STEM CELL CONTROL KIT 15 TESTS IVD ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABNORMALLY HIGH BLOOD CELL COUNT. A NEW LOT OF 340991 WAS MEASURED AND WAS FAR OFF THE MEDIAN VALUE ON THE SPEC SHEET AND DID NOT ENTER THE REFERENCE VALUE. WE TRIED MULTIPLE TIMES WITH DIFFERENT MEASURERS AND EQUIPMENT, BUT THE VALUE REMAINED HIGH. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING BD STEM CELL CONTROL KIT 15 TESTS IVD ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABNORMALLY HIGH BLOOD CELL COUNT. A NEW LOT OF 340991 WAS MEASURED AND WAS FAR OFF THE MEDIAN VALUE ON THE SPEC SHEET AND DID NOT ENTER THE REFERENCE VALUE. WE TRIED MULTIPLE TIMES WITH DIFFERENT MEASURERS AND EQUIPMENT, BUT THE VALUE REMAINED HIGH. 1.ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2.WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3.IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4.WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING BD STEM CELL CONTROL KIT 15 TESTS IVD ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABNORMALLY HIGH BLOOD CELL COUNT. A NEW LOT OF 340991 WAS MEASURED AND WAS FAR OFF THE MEDIAN VALUE ON THE SPEC SHEET AND DID NOT ENTER THE REFERENCE VALUE. WE TRIED MULTIPLE TIMES WITH DIFFERENT MEASURERS AND EQUIPMENT, BUT THE VALUE REMAINED HIGH. 1.ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES 2.WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3.IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4.WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680474 BD STEM CELL CONTROL KIT 15 TESTS IVD COUNTER, DIFFERENTIAL CELL GGL BECTON DICKINSON AND COMPANY BD BIOSCIENCES BC1123 00382903409914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown