BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ STEM CELL ENUMERATION

    MDR report key: 18314288 · Received December 12, 2023

    Report

    Report Number
    2916837-2023-00227
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    December 6, 2023
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GKZ
    UDI-DI
    00382906642318
    PMA / PMN Number
    BK231031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AFTER USING BD¿ STEM CELL ENUMERATION ERRONEOUS RESULTS WERE ACQUIRED. D.1. MEDICAL DEVICE BRAND NAME: BD¿ STEM CELL ENUMERATION. D.1 MEDICAL DEVICE TYPE: GKZ. D.2. COMMON DEVICE NAME: COUNTER, DIFFERENTIAL CELL. D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON CARIBE LTD. ¿ CAYEY, PR / 00737. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1 - REPORTING OFFICE - (B)(6). G.1 MANUFACTURING LOCATION: BECTON, DICKINSON CARIBE LTD. ¿ CAYEY, PR / 00737 G.1 - REPORTING OFFICE CONTACT - (B)(6). G.1 - MANUFACTURING SITE CONTACT - (B)(4). G.5. PMA / 510(K)#: BK231031.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE LEUKOCYTE VALUES FOUND ON THEIR AUTOMATED COUNTING SYSTEM WITH THOSE FOUND BY CYTOMETRY WERE OVERESTIMATED WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: TESTING ON 91-0786 BATCH 23128 MATERIAL DESCRIPTION POUCHED ABSOLUTE COUNT TUBES WAS PERFORMED WITHIN 6 MONTHS OF THE COMPLAINT, THE RESULTS SHOWED THAT THE PRODUCT WAS PERFORMING AS INTENDED. BHR REVIEW SHOWED THAT FOR PART 91-0786 (POUCHED ABSOLUTE COUNT) BATCH 23128 WAS REVIEWED. THE PRODUCT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. POTENTIAL CAUSE WAS NOT DETERMINED, THE ISSUE WAS RESOLVED WITH A REPLACEMENT KIT FOR 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

    G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. 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 ENUMERATION ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE USING YOUR BD SCE KIT AND TRUCOUNT TUBES. SPORADICALLY WE SEE THAT BEADS ARE LOWER THAN EXPECTED. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING BD¿ STEM CELL ENUMERATION ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE USING YOUR BD SCE KIT AND TRUCOUNT TUBES. SPORADICALLY WE SEE THAT BEADS ARE LOWER THAN EXPECTED. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES. 2.WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE USING YOUR BD SCE KIT AND TRUCOUNT TUBES. SPORADICALLY WE SEE THAT BEADS ARE LOWER THAN EXPECTED. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES 2.WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NOT APPLICABLE 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289499 BD¿ STEM CELL ENUMERATION COUNTER, DIFFERENTIAL CELL GKZ BECTON DICKINSON CARIBE LTD. UNKNOWN 00382906642318
    1770784 BD¿ STEM CELL ENUMERATION COUNTER, DIFFERENTIAL CELL GKZ BECTON DICKINSON CARIBE LTD. UNKNOWN 00382906642318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown