BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO

    MDR report key: 10684852 · Received October 15, 2020

    Report

    Report Number
    2916837-2020-00193
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 27, 2020
    Report Date
    August 6, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906573384
    PMA / PMN Number
    K141468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSCANTO IVD 10 COLOR CONFIGURATION PART # 657338, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT THAT THEIR EXPERIMENTAL RESULTS ARE NOT IDEAL. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 27SEP2019 TO DATE 27SEP2020. COMPLAINT TREND: THERE ARE 6 COMPLAINTS RELATED TO THE ISSUE OF ERRONEOUS RESULTS WITHIN THE DATE RANGE; P DATE RANGE FROM 27SEP2019 TO DATE 27SEP2020. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #657338 SERIAL # (B)(6), FILE #(B)(4), WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF WHY THE CUSTOMER WAS SEEING UNACCEPTABLE RESULTS WAS DUE THE OPTICAL PATH BEING OUT OF ALIGNMENT. OPTICS THAT ARE OUT OF CALIBRATION MAY LEAD TO UNEXPECTED RESULTS. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE AND CALIBRATED AND ALIGNED THE OPTICAL PATH. NO PARTS WERE REQUESTED FOR EVALUATION AS NOT PARTS WERE DAMAGED NOR REPLACED. AFTER THE REPAIR THE INSTRUMENT WAS TESTED AND WAS PERFORMING AS EXPECTED. ALTHOUGH THE UNEXPECTED RESULTS WERE FROM PATIENT SAMPLES FOR CLINICAL USE, NO PATIENT WAS TREATED NOR HARMED FROM INCORRECT RESULTS. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND NO IMPACT TO THE PATIENT¿S HEALTH. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED AND FUNCTIONING AS EXPECTED. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4)., INSTALL DATE: (B)(6) 2018, DEFECTIVE PART NUMBER: N/A, WORK ORDER NOTES: SUBJECT / REPORTED: PI-657338-FACSCANTO PLUS-EXPERIMENTAL RESULTS ARE NOT IDEAL. PROBLEM DESCRIPTION: FACSCANTO PLUS-EXPERIMENTAL RESULTS ARE NOT IDEAL, USE PATIENT SPECIMENS FOR TESTING. NO PATIENT TREATMENT WAS APPLIED, AND NO PATIENT WAS AFFECTED. CLINICAL USE, (B)(6). WORK PERFORMED: CALIBRATE THE OPTICAL PATH, AND THE INSTRUMENT RETURNS TO NORMAL USE. CAUSE: CALIBRATE THE OPTICAL PATH, AND THE INSTRUMENT RETURNS TO NORMAL USE. SOLUTION: CALIBRATE THE OPTICAL PATH, AND THE INSTRUMENT RETURNS TO NORMAL USE. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE NO PARTS WERE REPLACED. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100264RA, REVISION06/VERSION H, FACSCANTO 10-COLOR (CANTO PLUS) RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. ID: (B)(4) (0006-100266 FMEA CANTO PLUS). HAZARD: INCORRECT OUTPUT. CAUSE: DIODE AGING OVERTIME RESULTING IN LASER POWER FALLS OUT OF SPECIFICATION; HENCE QR AND SENSITIVITY ARE REDUCED; HENCE UNABLE TO RESOLVE DIM POPULATION. HARMFUL EFFECTS: INCORRECT RESULT. RISK CONTROLS: VENDOR RELIABILITY TESTING PERFORMED; ACCEPTABLE. PMT (B)(6) REPORT INDICATES GRADUAL CHANGE AND WILL HAVE ENOUGH WARNING TO REACT BEFORE THE IMPACT TAKES PLACE. IMPLEMENTATION VERIFICATION: VENDOR RELIABILITY DATA. STANDARD LABORATORY PRACTICE PER GLP AND CAP TO TRACK INSTRUMENT PERFORMANCE. EFFECTIVENESS VERIFICATION: REFERENCE IS MADE TO HW TECHNICAL REVIEW DATED 10/12/12. STANDARD LABORATORY PRACTICE PER GLP AND CAP. PROBABILITY: 1. SEVERITY: 3. RISK INDEX: 3. RESIDUAL RISK EVALUATION: ACCEPTABLE. NEW HAZARDS: NO. MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE WAS DUE TO THE OPTICAL PATH WAS OUT OF CALIBRATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF WHY THE CUSTOMER WAS SEEING UNACCEPTABLE RESULTS ON THE FACSCANTO WAS DUE THE OPTICAL PATH BEING OUT OF ALIGNMENT. THE FSE CALIBRATED AND ALIGNED THE OPTICAL PATH FOR OPTIMUM PERFORMANCE. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE ERRONEOUS RESULTS. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD FACSCANTO¿ ERRONEOUS RESULTS OCCURRED ON PATIENT SAMPLE. CONFIRMATORY TESTS PERFORMED AND THE ISSUE REMAINS. INCORRECT RESULTS WERE NOT REPORTED AND THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE WAS USED DURING THIS TEST.CUSTOMER CONDUCTED A REPEAT/DIFFERENT TEST TO CONFIRM THE RESULTS, THE PROBLEM REMAINS. THERE WAS NO IMPACT TO PATIENT SAMPLES AND NO PHYSICAL HARM/INJURY DUE TO THE ISSUE. NO INCORRECT RESULTS BEEN USED. NO DELAY OR ALTERCATION OF TREATMENT DUE TO THIS PROBLEM.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER PHONE #: (B)(6). 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 DURING USE WITH A BD FACSCANTO¿ ERRONEOUS RESULTS OCCURRED ON PATIENT SAMPLE. CONFIRMATORY TESTS PERFORMED AND THE ISSUE REMAINS. INCORRECT RESULTS WERE NOT REPORTED AND THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE WAS USED DURING THIS TEST. CUSTOMER CONDUCTED A REPEAT/DIFFERENT TEST TO CONFIRM THE RESULTS, THE PROBLEM REMAINS. THERE WAS NO IMPACT TO PATIENT SAMPLES AND NO PHYSICAL HARM/INJURY DUE TO THE ISSUE. NO INCORRECT RESULTS BEEN USED. NO DELAY OR ALTERCATION OF TREATMENT DUE TO THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152671 BD FACSCANTO COUNTER, DIFFERENTIAL CELL OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 657338 NA 00382906573384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other