BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS LWA

    MDR report key: 10213040 · Received June 30, 2020

    Report

    Report Number
    2916837-2020-00036
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 8, 2020
    Report Date
    March 18, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR, ROOT CAUSE AND RISK ANALYSIS, THE REPORTED COMPLAINT WAS DETERMINED BY AN FSE (FIELD SERVICE ENGINEER) THAT THE CAUSE OF CARRYOVER WAS FROM INSUFFICIENT SPINDLE CLEANSE WASH VOLUME. IT WAS FOUND THAT BETWEEN TUBE CYCLES, THE SPINDLE CLEANSE OUTPUT AT THE CELL WASH SHROUD WAS 1.5ML. THE FLOW RESTRICTOR WAS REPLACED WITH AN NSI (NON-STOCK INVENTORY) PART TO PROVIDE BETTER FLOW VOLUME. AFTER THE REPAIR, THE TEST PASSED CARRYOVER SPECIFICATION. ALTHOUGH A FALSE POSITIVE WAS INITIALLY OBTAINED DUE TO THE RESULT OF THIS, NO SAMPLES NOR ERRONEOUS RESULTS WERE USED FOR PATIENT TREATMENT. NO PARTS WERE REQUESTED TO BE RETURNED FOR EVALUATION BECAUSE THE FLOW RESTRICTOR IS NOT RETURNABLE AND WAS DISCARDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE FALSE POSITIVE RESULTS ON PATIENT SAMPLES WITH A BD FACS¿ LWA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING ISSUES WITH THE OLD LWA WHEN THE TCELL TUBE IS PLACED BEFORE OUR B-CELL TUBE IN THE LWA CAROUSEL, WE HAVE CARRY OVER STAINING FROM THE T-CELL TUBE INTO THE B-CELL TUBE AND ARE GIVING PATIENTS CLL WHEN THEY DON¿T HAVE IT. I STAINED 5 T-CELL TUBES AND PLACED A H2O TUBE IN BETWEEN EACH ONE, PROCESSED ON THE LWA. RAN THEM ON THE CANTO IN THAT SAME ORDER. ANALYZED AND YOU CAN SEE THAT THERE ARE CELLS IN THE H2O TUBE THAT SHOULD NOT BE THERE AND THESE WILL SHOW UP IN OUR B-CELL TUBE GIVING FALSE POSITIVE RESULTS. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? NO. ADDITIONALLY, ON 2020-06-23 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1) ¿YES¿ THE CARRY OVER ISSUE WAS OBSERVED ON PATIENT SAMPLES, SINCE THAT IS ALL THEY RUN ON THE INSTRUMENT. 2) ¿NO¿, NO PATIENTS WERE REDRAWN AND THERE WAS NO DELAY IN TREATMENT DUE TO THE ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE FALSE POSITIVE RESULTS ON PATIENT SAMPLES WITH A BD FACS¿ LWA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING ISSUES WITH THE OLD LWA WHEN THE TCELL TUBE IS PLACED BEFORE OUR B-CELL TUBE IN THE LWA CAROUSEL, WE HAVE CARRY OVER STAINING FROM THE T-CELL TUBE INTO THE B-CELL TUBE AND ARE GIVING PATIENTS CLL WHEN THEY DON¿T HAVE IT. I STAINED 5 T-CELL TUBES AND PLACED A H2O TUBE IN BETWEEN EACH ONE, PROCESSED ON THE LWA. RAN THEM ON THE CANTO IN THAT SAME ORDER. ANALYZED AND YOU CAN SEE THAT THERE ARE CELLS IN THE H2O TUBE THAT SHOULD NOT BE THERE AND THESE WILL SHOW UP IN OUR B-CELL TUBE GIVING FALSE POSITIVE RESULTS. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? NO. ADDITIONALLY, ON 2020-06-23 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿YES¿ THE CARRY OVER ISSUE WAS OBSERVED ON PATIENT SAMPLES, SINCE THAT IS ALL THEY RUN ON THE INSTRUMENT. ¿NO¿, NO PATIENTS WERE REDRAWN AND THERE WAS NO DELAY IN TREATMENT DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680151 BD FACS LWA STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other