BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSPRESTO REAGENT CARTRIDGE

    MDR report key: 11627109 · Received April 7, 2021

    Report

    Report Number
    2916837-2021-00155
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 9, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ PROBLEM STATEMENT: CUSTOMER REPORTED THAT TWO CARTRIDGES FROM BATCH 1063641 GAVE NO RESULTS. ¿ MANUFACTURING DEFECT TREND: THERE ARE NO QNS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. DATE RANGE: 09 MAR 2020 ¿ 09 MAR 2021. ¿ COMPLAINT HISTORY REVIEW: THERE ARE 3 COMPLAINTS RELATED TO THE REPORTED COMPLAINT INCLUDING THIS COMPLAINT. DATE RANGE: 09 MAR 2020 ¿ 09 MAR 20201. ¿ BATCH HISTORY RECORD (BHR) REVIEW: BATCH RECORD 657681-1063641 WAS REVIEWED. THE MATERIAL MET FINAL PRODUCT SPECIFICATIONS PRIOR TO RELEASE. ¿ RETURNED SAMPLE ANALYSIS UNOPENED SAMPLES FOR RETURN FROM THE CUSTOMER WERE NOT AVAILABLE. PHOTOS WERE PROVIDED BY THE CUSTOMER IN LIEU OF SAMPLE RETURN. PHOTOS WERE EVALUATED AND WERE OF THE INSTRUMENT DISPLAY SCREEN AND SHOWED XXX FOR THE CD4 RESULTS AND A 6B0F ERROR CODE. A 6B0F ERROR INDICATES TOO MANY MOVING CELLS IN THE IMAGING CHANNEL. WHEN A 6B0F ERROR IS GENERATED BY THE FACSPRESTO INSTRUMENT, THE INSTRUMENT WILL ABORT THE RUN AND CD4 ABSOLUTE/%CD4 RESULTS WILL NOT BE REPORTED. ¿ RETAIN SAMPLE ANALYSIS: CARTRIDGES FROM RETAIN SAMPLE KIT 657681-1063641 WERE TESTED FOR THE 6B0F ERROR CODE. DUE TO THE LIMITED NUMBER OF CARTRIDGES LEFT IN THE RETAIN SAMPLE KIT, 15 CARTRIDGES, REPRESENTING HALF OF THE 30 TOTAL CARTRIDGES REMAINING, WERE RUN ON THE FACSPRESTO INSTRUMENT USING WHOLE BLOOD AS SAMPLE MATERIAL. ALL CARTRIDGES TESTED WERE SUCCESSFULLY READ BY THE INSTRUMENT AND GAVE CD4 ABSOLUTE COUNT/%CD4/HB RESULTS. THERE WERE NO ERROR CODES REPORTED BY THE INSTRUMENT. THERE WERE NO CARTRIDGE LEAKS. CUSTOMER COMPLAINT WAS NOT REPLICATED AND COULD NOT BE CONFIRMED. RETAIN TEST RESULTS ARE ATTACHED (FILE NAME: 657681-1063641 RETAIN RESULTS). ¿ ROOT CAUSE ANALYSIS: BASED ON THE CUSTOMER PHOTOS OF THE 6B0F ERROR CODE, IT WAS POSSIBLE THAT THE BLOOD SAMPLE MAY HAVE LEAKED BEYOND THE IMAGING CHANNEL CAUSING CELLS TO MOVE/DRIFT WITHIN THE CHANNEL. ALTOGETHER, BASED ON THE COMPLAINT PHOTOS AND INVESTIGATION RESULTS, ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. ¿ RISK REVIEW RISK MANAGEMENT FILE (B)(4), REVISION 07 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES NO. HAZARD #: 3.1.89 ¿ INADEQUATE SAMPLE VOLUME. HAZARD: CAUSE: SAMPLE LEAKS OUTSIDE OF IMAGING CHANNEL. HARMFUL EFFECTS: INACCURATE RESULT. INITIAL PROBABILITY: 3. INITIAL SEVERITY: 3. INITIAL RISK INDEX: 9. RISK CONTROL: OPTIMIZE WELDING PROCESS INCLUDING PROCESS VALIDATION AND SCREENING OF RAW MATERIALS. ALGORITHM WILL CAPTURE MOVING/DRIFTING CELLS. IMPLEMENTATION VERIFICATION: VP10763 OQ/PQ OF THE WELDING FOR FACSPRESTO CARTRIDGES EFFECTIVENESS VERIFICATION: VP10763. RESIDUAL PROBABILITY: 1. RESIDUAL SEVERITY: 3. RESIDUAL RISK INDEX: 3. NEW HAZARDS: NO . MITIGATION(S) SUFFICIENT: YES. ¿ CONCLUSION: BASED ON THE REVIEW OF THE MANUFACTURING DEFECT TREND, COMPLAINT TREND, BATCH RECORD, RISK MANAGEMENT FILE, AND INVESTIGATION RESULTS, THE COMPLAINT WAS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSPRESTO REAGENT CARTRIDGE NO RESULT (XXX) WAS OBTAINED ON PATIENT SAMPLES. REPEATED WITH NEW CARTRIDGE AND ISSUE REMAINED. RESULT WAS OBTAINED UPON TESTING WITH A THIRD CARTRIDGE, HOWEVER, IT WAS A LOW COUNT AND IS PRESUMED TO BE INACCURATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUN PATIENT SAMPLE USING BD FACSPRESTO CARTRIDGE. REPEATED THE SAME SAMPLE ON TWO CARTRIDGE FROM THE SAME LOT. BOTH SHOWN XXX RESULT. NEXT, USER DILUTED THE SAME PATIENT SAMPLE USING SALINE IN 1:1. AND RUN ON 3RD CARTRIDGE FROM THE SAME LOT. THE 3RD CARTRIDGE SHOWN THE CD4 AB COUNT RESULT. LOOKING TO THE PATIENT RESULT, IT FOUND THAT THE CD4 ABS COUNT IS WITHIN THE LINEARITY RANGE THAT BD FACSPRESTO HAS VALIDATED. USER RAISED CONCERN AND LIKE TO KNOW THE REASON BEHIND THE RESULT XXX SHOWN ON THE 1ST AND 2ND CARTRIDGE. BETWEEN, SHE LIKE TO VERIFY THE RESULT ACCURACY FOR THE DILUTED SAMPLE. USER HAS ENCOUNTERED THE XXX RESULT BEFORE THIS INCIDENT, THE TROUBLESHOOTING THAT SHE DONE WAS REPEAT THE CARTRIDGE RUNS ON THE MACHINE, AND USER ABLE TO HAVE THE CD4 ABS COUNT % ON THE SECOND RUN.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHILE USING BD FACSPRESTO REAGENT CARTRIDGE NO RESULT (XXX) WAS OBTAINED ON PATIENT SAMPLES. REPEATED WITH NEW CARTRIDGE AND ISSUE REMAINED. RESULT WAS OBTAINED UPON TESTING WITH A THIRD CARTRIDGE, HOWEVER, IT WAS A LOW COUNT AND IS PRESUMED TO BE INACCURATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUN PATIENT SAMPLE USING BD FACSPRESTO CARTRIDGE. REPEATED THE SAME SAMPLE ON TWO CARTRIDGE FROM THE SAME LOT. BOTH SHOWN XXX RESULT. NEXT, USER DILUTED THE SAME PATIENT SAMPLE USING SALINE IN 1:1. AND RUN ON 3RD CARTRIDGE FROM THE SAME LOT. THE 3RD CARTRIDGE SHOWN THE CD4 AB COUNT RESULT. LOOKING TO THE PATIENT RESULT, IT FOUND THAT THE CD4 ABS COUNT IS WITHIN THE LINEARITY RANGE THAT BD FACSPRESTO HAS VALIDATED. USER RAISED CONCERN AND LIKE TO KNOW THE REASON BEHIND THE RESULT XXX SHOWN ON THE 1ST AND 2ND CARTRIDGE. BETWEEN, SHE LIKE TO VERIFY THE RESULT ACCURACY FOR THE DILUTED SAMPLE. USER HAS ENCOUNTERED THE XXX RESULT BEFORE THIS INCIDENT, THE TROUBLESHOOTING THAT SHE DONE WAS REPEAT THE CARTRIDGE RUNS ON THE MACHINE, AND USER ABLE TO HAVE THE CD4 ABS COUNT % ON THE SECOND RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529161 BD FACSPRESTO REAGENT CARTRIDGE NA GKL BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 1063641

    Patients

    Seq Age Sex Outcome Treatment
    1