BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 17637991 · Received August 28, 2023

    Report

    Report Number
    2916837-2023-00172
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 2, 2023
    Report Date
    March 2, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906628787
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. G.5. PMA / 510(K)#: K170974 G.5. PMA / 510(K)#: K201814. H.3. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: G.1. REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. G.2. REPORTING OFFICE CONTACT: (B)(6) - MDR. G.4. MANUFACTURING SITE CONTACT: (B)(6) - MDR. H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER EXPERIENCING CARRYOVER ISSUES ON THE FACSLYRIC WAS DETERMINED TO BE PLUGGED SIT ASSEMBLY. FSE PERFORMED SYSTEM CHECKS INCLUDING A SIT FLUSH, P2 AND V8 ASSEMBLY. FSE THEN REMOVED AND CLEANED& FLUSHED THE SIT ASSEMBLY. AFTERWARDS, THE INSTRUMENT IS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED TO DETERMINE IF FURTHER ACTION IS NEEDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. CALLED AND SPOKE WITH CUSTOMER AND CUSTOMER STATED THAT THEY WERE PATIENT SAMPLES BUT THEY DETECTED THE ISSUE RIGHT AWAY AND STOPPED USING THIS LYRIC. NO FALSE RESULTS WERE REPORTED TO PATIENTS OR DOCTORS AS A RESULT OF THIS ISSUE. IT WAS REPORTED BY THE CUSTOMER THAT CARRY OVER OF SAMPLES. SIT FLUSH MAY NOT BE FUNCTIONING PROPERLY. NO FALSE RESOLVES WERE REPORTED TO PATIENTS OR DOCTORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. CALLED AND SPOKE WITH CUSTOMER AND CUSTOMER STATED THAT THEY WERE PATIENT SAMPLES BUT THEY DETECTED THE ISSUE RIGHT AWAY AND STOPPED USING THIS LYRIC. NO FALSE RESULTS WERE REPORTED TO PATIENTS OR DOCTORS AS A RESULT OF THIS ISSUE. IT WAS REPORTED BY THE CUSTOMER THAT CARRY OVER OF SAMPLES. SIT FLUSH MAY NOT BE FUNCTIONING PROPERLY. NO FALSE RESOLVES WERE REPORTED TO PATIENTS OR DOCTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339933 BD FACSLYRIC¿ FLOW CYTOMETRIC REAGENTS AND ACCESS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA 00382906628787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown