BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LWA

    MDR report key: 21937919 · Received April 30, 2025

    Report

    Report Number
    3027394506-2025-00021
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 20, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    UDI-DI
    00382903374083
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CARRYOVER WAS DUE TO CLOGGED FITTINGS AND RESTRICTORS ON THE INSTRUMENT. THE ISSUE WAS RESOLVED AFTER THE CELL WASH ASSEMBLY WAS REPLACED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ LWA, THE CUSTOMER ENCOUNTERED CARRYOVER INVOLVING PATIENT SAMPLES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MACHINE HAVE CARRY OVER ISSUE. CUSTOMER ALREADY PERFORMED CLEANING TROUBLESHOOTING BUT ISSUE PERSIST" CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. CARRYOVER BETWEEN PATIENT SAMPLES 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SYSTEM HAS EVIDENCE OF CARRYOVER BETWEEN SAMPLES. CUSTOMER HAS HAD TO PROCESS SAMPLES BY HAND AND NOT USE LWA CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. CARRYOVER BETWEEN PATIENT SAMPLES 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SYSTEM HAS EVIDENCE OF CARRYOVER BETWEEN SAMPLES. CUSTOMER HAS HAD TO PROCESS SAMPLES BY HAND AND NOT USE LWA PATIENT SAMPLES CHECKLIST: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ LWA, THE CUSTOMER ENCOUNTERED CARRYOVER INVOLVING PATIENT SAMPLES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MACHINE HAVE CARRY OVER ISSUE. CUSTOMER ALREADY PERFORMED CLEANING TROUBLESHOOTING BUT ISSUE PERSIST". CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THEIR CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. CARRYOVER BETWEEN PATIENT SAMPLES 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SYSTEM HAS EVIDENCE OF CARRYOVER BETWEEN SAMPLES. CUSTOMER HAS HAD TO PROCESS SAMPLES BY HAND AND NOT USE LWA. CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THEIR CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. CARRYOVER BETWEEN PATIENT SAMPLES 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SYSTEM HAS EVIDENCE OF CARRYOVER BETWEEN SAMPLES. CUSTOMER HAS HAD TO PROCESS SAMPLES BY HAND AND NOT USE LWA PATIENT SAMPLES CHECKLIST: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967032 BD FACS¿ LWA STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382903374083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown