BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCALIBUR¿ FLOW CYTOMETER

    MDR report key: 16215381 · Received January 20, 2023

    Report

    Report Number
    2916837-2023-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903429752
    PMA / PMN Number
    K923790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITAL REPORTER PHONE # (B)(6). PMA / 510(K)#: K973483. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY. SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD, PART # 342975 AND SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING GRAPH ANOMALY ON (B)(6)2023. THIS POSES THE RISK OF PRODUCING ERRONEOUS RESULTS THAT MIGHT IMPACT PATIENT DIAGNOSIS AND TREATMENT. THE INSTRUMENT WAS REPAIRED AND FOUND TO BE FUNCTIONING AS EXPECTED, AND NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED DUE TO THIS ISSUE. MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 02JAN2022 TO 02JAN2023. DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 342975, SERIAL # (B)(6), FILE # (B)(4), WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. COMPLAINT HISTORY REVIEW: THERE ARE (B)(4) COMPLAINTS RELATED TO THE AS REPORTED CODE 1 ¿ RESULT - UNEXPECTED; PR# (B)(4), 4391 DATE RANGE FROM 02JAN2022 TO 02JAN2023. RETURNED SAMPLE ANALYSIS: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE NO PARTS WERE REPLACED. SERVICE HISTORY REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4); CASE # (B)(4). INSTALL DATE: 29OCT2014. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: (B)(4) /FACSCALIBUR - PATTERN ANOMALY. PROBLEM DESCRIPTION: FACSCALIBUR - ABNORMAL GRAPHIC, CLINICAL USE, RESULTS NOT USED IN PATIENT DIAGNOSIS XUCHANG ENGINEER FEEDBACK: PAID. WORK PERFORMED : THE CALIBRATION SIGNAL, THE QUALITY CONTROL PASSED, THE TEST SAMPLE WAS NORMAL, AND THE INSTRUMENT WAS RUNNING NORMALLY. CAUSE: THE OPTICAL PATH NEEDS TO BE CALIBRATED. SOLUTION: THE CALIBRATION SIGNAL, THE QUALITY CONTROL PASSED, THE TEST SAMPLE WAS NORMAL, AND THE INSTRUMENT WAS RUNNING NORMALLY. PARTS REPLACED: N/A. LABELING / PACKAGING REVIEW: N/A. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 342973RA, REV. 04/VERS. D, RISK ANALYSIS FACSCALIBUR PROD FAMILY WAS REVIEWED. THIS FILE DID NOT CONTAIN THE APPROPRIATE HAZARDS AND MITIGATIONS, AND AN ECO HAS BEEN OPENED TO ASSESS ADDITIONAL HAZARDS AND THEIR RISK LEVELS. ECR #(B)(4) HAS BEEN CREATED AND WILL REVISE THE EXISTING CALIBUR RISK ANALYSIS DOCUMENT TO INCLUDE CAUSES, MITIGATIONS, AND RISK RATINGS RELATED TO ERRONEOUS RESULTS. POTENTIAL CAUSES: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE OF THE GRAPH ANOMALY WAS A CALIBRATION/ALIGNMENT ISSUE OF THE OPTICAL PATH. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR REVIEW, RISK ANALYSIS, AND SERVICE ACTIVITY REVIEW, THE POTENTIAL CAUSE OF THE GRAPH ANOMALY WAS A CALIBRATION/ALIGNMENT ISSUE OF THE OPTICAL PATH. THE CUSTOMER REPORTED A COMPLAINT REGARDING AN ABNORMAL GRAPHIC AND A PATTERN ANOMALY. THE FIELD SERVICE REPRESENTATIVE (FSR) CONFIRMED THAT THE OPTICAL PATH WAS NOT CALIBRATED. THE FSR PROCEEDED TO ADJUST THE SIGNAL. AFTER THE WORK PERFORMED, THE ISSUE WAS RESOLVED. THE INSTRUMENT IS CONFIRMED TO PERFORMING AS INTENDED. ALTHOUGH THE UNEXPECTED RESULTS WERE FROM PATIENT SAMPLES, NO PATIENT WAS TREATED NOR HARMED FROM INCORRECT RESULTS. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSTIC DECISION AND WAS NOT REPORTED TO THE CLINICIAN. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF THE GRAPH ANOMALY WAS A CALIBRATION/ALIGNMENT ISSUE OF THE OPTICAL PATH. THE CUSTOMER REPORTED A COMPLAINT REGARDING AN ABNORMAL GRAPHIC AND A PATTERN ANOMALY. THE FIELD SERVICE REPRESENTATIVE (FSR) CONFIRMED THAT THE OPTICAL PATH WAS NOT CALIBRATED. THE FSR PROCEEDED TO ADJUST THE SIGNAL. AFTER THE WORK PERFORMED, THE ISSUE WAS RESOLVED. THE INSTRUMENT IS CONFIRMED TO PERFORMING AS INTENDED. BASED ON THE INVESTIGATION RESULTS A CAPA IS NOT REQUIRED BECAUSE THE ISSUE WAS RESOLVED AND THERE WAS NO IMPACT TO CUSTOMER AND PATIENT HEALTH OR SAFETY. SUPPORTING DOCUMENT: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR - ABNORMAL GRAPHICS, CLINICAL USE, RESULTS NOT USED FOR PATIENT DIAGNOSIS, OUT OF WARRANTY EQUIPMENT, QUOTE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR - ABNORMAL GRAPHICS, CLINICAL USE, RESULTS NOT USED FOR PATIENT DIAGNOSIS, OUT OF WARRANTY EQUIPMENT, QUOTE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130109 BD FACSCALIBUR¿ FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 342975 00382903429752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown