BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿ 2L6C INSTRUMENT

    MDR report key: 15553209 · Received October 6, 2022

    Report

    Report Number
    2916837-2022-00285
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 30, 2022
    Report Date
    September 19, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    K201814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6: SCOPE OF ISSUE: SCOPE OF CUSTOMER COMPLAINT ON ¿BARCODE DAMAGED AND CANNOT BE READ¿ IS FOR KIT FC BEADS 7 COLOR CE/IVD MATERIAL 656867 LOT 2011890. PROBLEM STATEMENT: CUSTOMER UNABLE TO SCAN OR READ THE BARCODE LABEL CONTAINING THE BEAD LOT FILE INFORMATION FOR KIT FC BEADS 7 COLOR CE/IVD MATERIAL 656867 LOT 2011890. INVESTIGATION SUMMARY: MANUFACTUING DEFECT TREND: FROM 29SEP2021 TO 29SEP2022 THERE ARE NO QNS CREATED FOR MATERIAL 656867 RELATED TO BARCODE BEAD LOT FILE LABEL. RELATED QN(S): N/A. COMPLAINT HISTORY REVIEW: FROM 29SEP2021 TO 29SEP2022 THERE ARE 11 PIRS CREATED FOR MATERIAL 656867 RELATED TO BARCODE LABEL SCANNING ISSUE. PIRS 3952601, 4058308, 4284462, 4362282, 4459276, 4461687, 4600808, 5457874, 5682511, 5765006, AND THIS PIR 6193143. BATCH HISTORY RECORD REVIEW: PRODUCT BATCH RECORDS FOR MATERIAL 656867 LOT 2011890 WAS REVIEWED. ALL MANUFACTURING AND QUALITY SPECIFICATIONS WERE MET FOR MATERIAL 656867 LOT 2011890. RESULTS OF THE REVIEW DETERMINED NO NON-CONFORMANCE REPORT WERE FOUND AND MATERIAL COMPLIED AND MET ALL MANUFACTURING SPECIFICATIONS AS DESIGNED PRIOR TO RELEASE. BEAD LOT FILES (ELECTRONIC AND BARCODE) WERE SUCCESSFULLY CREATED PER QC SPECIFICATION AND SAMPLES OF BARCODE BEAD LOT FILE LABELS WERE QC TESTED PRIOR TO RELEASE OF THE PRODUCT. ¿RETAIN SAMPLE ANALYSIS: RETAIN SAMPLE FOR MATERIAL 656867 LOT 2011890 WAS TESTED AND EVALUATED ON 3 DIFFERENT BRANDS OF BARCODE SCANNERS (SYMBOL, ZEBRA, AND BD PROVIDED DATALOGIC SCANNERS). ALL 3 SCANNERS SCANNED THE RETAIN BARCODE LABEL SUCCESSFULLY WITH NO ISSUES OR ERRORS ENCOUNTERED. BARCODE BEAD LOT FILE INFORMATION WAS ALSO SUCCESSFULLY UPLOADED INTO FACSUITE SOFTWARE LIBRARY. RETURNED SAMPLE ANALYSIS: NO TASK WAS CREATED TO REQUEST FOR THE RETURN OF THE BARCODE LABEL. USED QA RETAIN OF BARCODE BEAD LOT FILE LABEL FOR MATERIAL 656867 LOT 2011890. BD DID NOT RECEIVE ANY PICTURE OR ACTUAL BARCODE LABEL FROM CUSTOMER FOR REVIEW AND TESTING. ADDITIONAL TESTING WAS PERFORMED ON 3 DIFFERENT BRANDS OF BARCODE SCANNERS (SYMBOL, ZEBRA, AND BD PROVIDED DATALOGIC SCANNERS) USING QA RETAIN OF BARCODE LABEL FOR 656867 LOT 2011890. BASED ON THE RETAIN TESTING THE REPORTED ISSUE WAS NOT IDENTIFIED. ALL 3 SCANNERS SCANNED THE RETAIN BARCODE LABEL SUCCESSFULLY WITH NO ISSUES OR ERRORS ENCOUNTERED. BARCODE BEAD LOT FILE INFORMATION WAS ALSO SUCCESSFULLY UPLOADED INTO THE FACSUITE SOFTWARE LIBRARY. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED USING QA RETAIN OF THE BARCODE LABEL FOR MATERIAL 656867 LOT 2011890 AND BASED ON THE RETAIN TESTING THE REPORTED ISSUE WAS NOT REPLICATED AND WAS NOT CONFIRMED AS A DEFECT. REVIEW OF THE BATCH HISTORY RECORD DETERMINED NO NON-CONFORMANCE REPORT WERE FOUND AND MATERIALS COMPLIED AND MET ALL MANUFACTURING SPECIFICATIONS AS DESIGNED PRIOR TO RELEASE. THE BEAD LOT FILES (ELECTRONIC AND BARCODE) WERE SUCCESSFULLY CREATED PER SPECIFICATION AND SAMPLES OF BARCODE BEAD LOT FILE LABELS WERE QC TESTED PRIOR TO THE RELEASE OF THE PRODUCT. BEAD LOT FILES CAN ALSO BE DOWNLOADED FROM THE BD BIOSCIENCES WEBSITE PER TECHNICAL DATA SHEET (TDS) INCLUDED IN THE KIT BOX. RISK REVIEW: RISK MANAGEMENT FILE (B)(4) BD FACSLYRIC SYSTEM RA REV. 08 WAS REVIEWED AND BASED ON THE REVIEW; THE RESIDUAL RISK EVALUATION WAS AFAP (AS FAR AS POSSIBLE). PER BENEFIT-RISK ANALYSIS, THE RISKS HAVE BEEN EVALUATED, REDUCED AS FAR AS POSSIBLE, AND NO NEW RISKS HAVE BEEN INTRODUCED. THE RISKS WERE RE-EVALUATED DURING DEVICE PERFORMANCE CLAIMS EVALUATION AND DETERMINED THAT RISKS DO NOT IMPACT USER SAFETY. HAZARD ID#: (B)(4). HAZARD: INCORRECT BEADS INFORMATION. CAUSES: INCORRECT BEADS INFORMATION INPUT FROM BARCODE READER. HARMFUL EFFECTS: INCORRECT RESULTS. WRONG SETUP. MISMATCH OF BEADS INFORMATION IN REPORTS. RESIDUAL SEVERITY: 3. RESIDUAL PROBABILITY: 3. RESIDUAL RISK INDEX: 9. POTENTIAL CAUSE: BECAUSE THE COMPLAINT IS NOT CONFIRMED, THERE IS NO ROOT CAUSE DETERMINED. CONCLUSION: BASED ON THE INVESTIGATION RESULT, COMPLAINT WAS NOT CONFIRMED AS A MANUFACTURING DEFECT. ATTACHED SUPPORTING DOCUMENT: SCREENSHOT OF FACSUITE LIBRARY WITH BEAD LOT FILE INFORMATION, FC BEAD KIT DETAIL SCANNED FROM SYMBOL, ZEBRA, AND BD PROVIDED DATALOGIC SCANNERS.

    Description of Event or Problem · 0

    HOLD FOR TG 10.21IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ 2L6C INSTRUMENT THAT THE BARCODE OF FC BEADS (LOT2011890) IS DAMAGED AND CANNOT BE READ THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER [RESULT] I WAS INFORMED THAT THE LOT DATA WAS SUCCESSFULLY IMPORTED. THE USER WILL USE IT NORMALLY. [PHENOMENON] THE BARCODE OF FC BEADS (LOT2011890) IS DAMAGED AND CANNOT BE READ. [RESPONSE] I SENT YOU AN EMAIL WITH THE URL OF THE WEBSITE AND HOW TO DOWNLOAD THE LOT DATA AND IMPORT IT INTO THE SUITE. [RESULT] IF THE PHENOMENON IS NOT IMPROVED, THE USER WILL CONTACT BD AGAIN. BARCODE OF FC BEADS (LOT2011890) IS DAMAGED AND CANNOT BE READ.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ 2L6C INSTRUMENT THAT THE BARCODE OF FC BEADS (LOT2011890) IS DAMAGED AND CANNOT BE READ THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. [RESULT] I WAS INFORMED THAT THE LOT DATA WAS SUCCESSFULLY IMPORTED. THE USER WILL USE IT NORMALLY. [PHENOMENON] THE BARCODE OF FC BEADS (LOT2011890) IS DAMAGED AND CANNOT BE READ. [RESPONSE] I SENT YOU AN EMAIL WITH THE URL OF THE WEBSITE AND HOW TO DOWNLOAD THE LOT DATA AND IMPORT IT INTO THE SUITE. [RESULT] IF THE PHENOMENON IS NOT IMPROVED, THE USER WILL CONTACT BD AGAIN. BARCODE OF FC BEADS (LOT2011890) IS DAMAGED AND CANNOT BE READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289475 BD FACSLYRIC¿ 2L6C INSTRUMENT BD FACSLYRIC¿ 2L6C INSTRUMENT OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown